Articles de revues : « RP-UPLC »

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Bharani Pandilla, Chitra K, Nalini C N, Ashok P et Vadivelan R. « Method development and validation of Ifetroban by RP-UPLC ». International Journal of Research in Pharmaceutical Sciences 11, n^o 3 (7 juillet 2020) : 3158–63. http://dx.doi.org/10.26452/ijrps.v11i3.2429.

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The purpose of this work is to develop and validate reverse phase Ultra performance liquid chromatography (UPLC) method for the rapid and precise determination of ifetroban sodium in its pure form and in formulations. A simple, specific, accurate, precise isocratic UPLC method for analysis of Ifetroban sodium was developed and validated using a Phenomenex C18 column (50 mm x 3.0 mm, 3µ) as the stationary phase, in conjunction using Triethyl amine buffer: methanol in the proportion of 25:75 with a flow rate of 1.0 mL/min, run time is 3 min and UV detector is used at 235 nm wavelength. The developed UPLC technique was found to be rapid as the retention time was 0.56 minutes for Ifetroban peak to elute. The developed UPLC technique was validated as per the ICH guidelines for specificity, linearity, accuracy, precision, robustness and found to be satisfactory. Linearity was established in the concentration range 100-300 µg/mL with correlation coefficient of 0.998 and the equation obtained is y = 0.635x + 0.639.The percentage recovery is 100.41. The method is rugged and is trouble free and transferable. The study showed that the developed UPLC technique can be used for the estimation of drug purity, stability, solubility and with no interference of pharmaceutical excipients from the active pharmaceutical ingredient. The precision, accuracy, robustness results obtained enables rapid quantification of ifetroban for quantitative analysis.

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Zhou, Jianwen, Caixia Han, Hui Cao, Shoumin Zhen, Zitong Yu, Xiaohui Li, Wujun Ma et Yueming Yan. « Fast identification of wheat 1BL.1RS translocation by reversed-phase ultra-performance liquid chromatography (RP-UPLC) ». Crop and Pasture Science 64, n^o 9 (2013) : 865. http://dx.doi.org/10.1071/cp13246.

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The 1BL.1RS chromosomal translocation in wheat is the result of replacement of the short arm of chromosome 1B of wheat by the short arm of chromosome 1R of rye, which had been widely used as a parental line in worldwide wheat breeding, resulting in a high percentage of wheat cultivars containing this translocation. A fast and reliable approach to identify this translocation is highly desirable in modern wheat breeding. This study compared reversed-phase ultra-performance liquid chromatography (RP-UPLC), acidic polyacrylamide gel electrophoresis (A-PAGE), liquid chromatography coupled to tandem mass spectrometry (LC-MS/MS), allelic-specific PCR, and reversed-phase high-performance liquid chromatography (RP-HPLC) approaches to identify the 1BL.1RS translocation in 76 bread wheat cultivars. Two gliadin bands in the Gli-B1 region of A-PAGE separation were confirmed by LC-MS/MS to be omega secalins from the 1BL.1RS translocation, and they can be used as reliable protein markers for identifying the translocation. A few specific minor peaks eluted at 12–13 min on the RP-UPLC patterns can readily differentiate the 1BL.1RS translocation. Of the 76 wheat cultivars tested, 40 were identified as carrying the 1BL.1RS translocation by RP-UPLC, which was consistent with the results of A-PAGE, HPLC, and PCR. Compared with other established methods, RP-UPLC showed a clear advantage in fast identification of the 1BL.1RS translocation with higher reliability and lower costs, and it is therefore ideal for large-scale screening of the 1BL.1RS translocation in wheat breeding.

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Takale, Nilesh, Neelakandan Kaliyaperumal, Gopalakrishnan Mannathusamy et Rajarajan Govindasamy. « Method Development and Validation for Quantitative Analysis of Anti-Histamine Promethazine Hydrochloride by RP-UPLC ». Oriental Journal Of Chemistry 37, n^o 1 (28 février 2021) : 33–39. http://dx.doi.org/10.13005/ojc/370103.

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The quantitative analysis method for the quantitative analysis of the anti-histaminic drug Promethazine Hydrochloride (PMZ•HCl) is stated by a straightforward, smooth, reliable and reverse step of the ultra-performing liquid chromatographic method (RP-UPLC). Following ICH quidelinesQ2(R1), the RP-UPLC method has been developed and checked. The uniform solution of 3.4% KH2PO4 solution in water, 7.0 pH with dilute KOH, ACN, andMeOH in ratio of 40:40:20, used as a mobile phase. The flow of 0.6 mL/minusing photo diode array detector / UV detector by with wavelength of 254 nm and runtime 3 min. This gives linearty from 80-120 % with correlation coefficient of 0.99988. Repeatability and intermediate precision shows relative standard deviation (percent RSD) of 0.52, 0.24 and a overall RSD of 0.43. Robustness studies show no indicative changes in SST requirements, like asymmetry factor, theoretical plate & percentage relative standard deviation. These criteria's values are well within their acceptability limit. The degradation of promethazine under different stress conditions has been studied and shows that all known impurities and degradants are well separated from promethazine peak.This RP-UPLC is descriptive and accurate.

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Vishnuvardhan, Chiguru, R. Srinivas et N. Satheeshkumar. « Development and validation of a UPLC method for screening potentially counterfeit anti-hypertensive drugs using design of experiment ». Anal. Methods 6, n^o 13 (2014) : 4610–16. http://dx.doi.org/10.1039/c4ay00384e.

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Lakshmi, D. Sri, Jane T. Jacob, D. Srinivasa Sastry et D. Satyanarayana. « Simultaneous Estimation of Metformin Glimeperide and Voglibose by RP-UPLC ». Asian Journal of Pharmaceutical Analysis 7, n^o 1 (2017) : 23. http://dx.doi.org/10.5958/2231-5675.2017.00005.9.

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Kumar, Kakumani Kishore, Chimalakonda Kameswara Rao, Maddala Vijaya Lakshmi et Khagga Mukkanti. « A Validated Stability Indicating RP-UPLC Method for Atrovastain Calcium ». American Journal of Analytical Chemistry 03, n^o 05 (2012) : 392–99. http://dx.doi.org/10.4236/ajac.2012.35052.

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Dubey, Somshankar, et Mahesh Duggirala. « SIMULTANEOUS ESTIMATION OF LAMIVUDINE, ABACAVIR AND DOLUTEGRAVIR BY UPLC METHOD ». International Journal of Applied Pharmaceutics 10, n^o 1 (6 janvier 2018) : 46. http://dx.doi.org/10.22159/ijap.2018v10i1.21156.

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Objective: To develop a simple, rapid, sensitive and effective reverse phase ultra-performance liquid chromatographic method (RP-UPLC) for simultaneous quantification of lamivudine, abacavir and dolutegravir in pure and tablet dosage forms.Methods: Chromatographic separation was performed by using Waters-ACQUITY UPLC system equipped with auto sampler, photodiode array (PDA) detector, zodiac sil RP C18 (4.6 mm × 250 mm, 3.0 µm) column, phosphate buffer (pH 3.0) and methanol in the ratio of 30:70 %v/v have been delivered at a flow rate of 0.25 ml/min and the detection was carried out using a Ultraviolet (UV) detector at a wavelength of 260 nm at ambient column temperature. The mobile phase was used as diluent.Results: The retention time (Rt) for lamivudine, abacavir and dolutegravir were 1.763, 2.247 and 3.175 min respectively. A good linear response was obtained in the range of 15-75 µg/ml, 30-150 µg/ml and 2.5-12.5 µg/ml, respectively. The Limit of Detection (LOD) values were found to be 0.021, 0.330 and 0.038 µg/ml, respectively and the Limit of Quantitation (LOQ) values were 0.056, 1.320 and 0.095 µg/ml, respectively.Conclusion: It was concluded that the developed RP-UPLC method was effective, suitable and conducive for analyzing lamivudine, abacavir and dolutegravir in pharmaceutical formulations. The method was quantitatively evaluated in terms of precision, linearity, accuracy (recovery), selectivity and robustness in accordance with standard guidelines.

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Rao, Sanapala Srinivasa, et A. Vijayalakshmi. « Analytical method development and validation of glipizide by RP-UPLC method ». RESEARCH JOURNAL OF PHARMACY AND TECHNOLOGY 14, n^o 3 (2021) : 1370–74. http://dx.doi.org/10.5958/0974-360x.2021.00244.4.

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Raju Sri Datla, V. V. S. S. N., et Manikandan Ayyar. « Development and validation of Stability-indicating RP-UPLC Method for the Simultaneous Determination of Ivacaftor, Tezacaftor and Elexacaftor in bulk and their Formulation ». Research Journal of Chemistry and Environment 25, n^o 12 (25 novembre 2021) : 107–15. http://dx.doi.org/10.25303/2512rjce107115.

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A simple reproducible stability indicating RP-UPLC method was developed for the simultaneous determination of Ivacaftor, Tezacaftor and Elexacaftor in their combined dosage forms using HSS C18, 1.8μm, 100mm x2.1 mm i.d. column. A mobile phase of phosphate buffer (10mM) pH-4.8 and acetonitrile in the ratio of 70: 30v/v mixture was used for separation and quantification of ivacaftor, tezacaftor and elexacaftor. The present drug analytes were run at a flow-rate of 0.3ml/ min at 30°C temperature. The injection volume was 2μL and with ultraviolet detection at 270nm. Under these conditions, elexacaftor, ivacaftor and tezacaftor were eluted at 0.72min, 1.4min and 1.9min respectively with a total run time shorter than 5min. The developed method was validated according to International Conference on Harmonization (ICH) guidelines. The developed RP-UPLC method was applied successfully for quality control assay of Ivacaftor, Tezacaftor and Elexacaftor in their combination drug product.

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Lee, Su-Bin, Yu-Jeong Yang, Sun-Hyung Lim, Yong Q. Gu et Jong-Yeol Lee. « A Rapid, Reliable RP-UPLC Method for Large-Scale Analysis of Wheat HMW-GS Alleles ». Molecules 26, n^o 20 (13 octobre 2021) : 6174. http://dx.doi.org/10.3390/molecules26206174.

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High-molecular-weight glutenin subunits (HMW-GS) account for only 10% of total wheat storage proteins, but play an important role in the processing quality of wheat flour. Therefore, identifying HMW-GS alleles associated with good end-use quality provides important information for wheat breeders. To rapidly, accurately and reproducibly identify HMW-GS, we established an optimized reversed-phase ultra-performance liquid chromatography (RP-UPLC) method. Separation parameters were optimized using an ACQUITY UPLC Protein BEH C4 column and stepwise ACN gradient, and the separation patterns and retention times (RTs) of 22 subunits were comparatively analyzed in 16 standard wheat cultivars. All HMW-GS proteins were well separated within about 5.5 min, and all analyses were complete within 12 min. We distinguished the 16 subunits based on RT, although three subunits in 1Bx (1Bx7/1Bx7OE and 1Bx17) and three subunits in 1By (1By8*, 1By9 and 1By15) had overlapping RTs; these were differentiated by SDS-PAGE. To distinguish 1Bx7 and 1Bx7OE, which differ in protein abundance, RP-UPLC was combined with PCR analysis of DNA junction markers. The optimized method was successfully applied to determine HMW-GS alleles in a large collection of bread wheat germplasm (1787 lines). This protocol is an appropriate option for selecting lines harboring favorable HMW-GS alleles in wheat breeding.

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Górnaś, Paweł, Inga Mišina, Ilze Grāvīte, Arianne Soliven, Edīte Kaufmane et Dalija Segliņa. « Tocochromanols composition in kernels recovered from different apricot varieties : RP-HPLC/FLD and RP-UPLC-ESI/MSn study ». Natural Product Research 29, n^o 13 (8 janvier 2015) : 1222–27. http://dx.doi.org/10.1080/14786419.2014.997727.

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Górnaś, Paweł, Inga Mišina, Baiba Lāce, Gunārs Lācis et Dalija Segliņa. « Tocochromanols composition in seeds recovered from different pear cultivars : RP-HPLC/FLD and RP-UPLC-ESI/MSn study ». LWT - Food Science and Technology 62, n^o 1 (juin 2015) : 104–7. http://dx.doi.org/10.1016/j.lwt.2015.01.025.

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Kuleshova, S. I., E. P. Simonova et O. N. Vysochanskaya. « Determination of Vancomycin B and Vancomycin Impurities by Liquid Chromatography ». Bulletin of the Scientific Centre for Expert Evaluation of Medicinal Products 11, n^o 4 (1 novembre 2021) : 246–54. http://dx.doi.org/10.30895/1991-2919-2021-11-4-246-254.

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The preferred test methods for control of product-related impurities in medicinal products are high-performance liquid chromatography (HPLC) with a fine sorbent, and ultra-performance liquid chromatography (UPLC), which allow for better chromatographic separation of active substances and related impurities, reduction of time costs, and saving of material resources. The aim of the study was to develop HPLC and UPLC test procedures and assess the chromatographic separation capacity and efficiency in order to improve determination of the main vancomycin component and related impurities. Materials and methods: vancomycin hydrochloride lyophilisate for oral solution and solution for injection, and vancomycin hydrochloride reference standard (USP RS) were used as test objects. Agilent 1290 Infinity liquid chromatography system, and Chromolith® Performance RP-18e, Kinetex C18, Nucleodur C18 Isis, Zorbax RRHD Eclipse Plus C18, and LiChrospher® RP-18 columns were used for the testing. Results: HPLC analysis using a Chromolith® column (100×4.6 mm) reduces the testing time by 10 minutes compared to the USP test procedure, and by 15 minutes compared to the British Pharmacopoeia procedure. The proposed test procedure requires less eluent and increases chromatographic separation efficiency. UPLC analysis using a Kinetex C18 column (50×4.6 mm, 2.6 μm) made it possible to reduce the testing time by two thirds compared to the British Pharmacopoeia procedure. The use of isocratic elution greatly simplified the testing. The testing time under the proposed chromatographic conditions was 10 minutes. Conclusions: the selected HPLC and UPLC test conditions made it possible to significantly reduce the time of testing, minimise the use of expensive reagents, and increase efficiency of chromatographic separation in the determination of vancomycin impurities and the main component Vancomycin B.

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Jin, Peng, Kai Yang, Ruining Bai, Mei Chen, Shilin Yang, Kebo Fu et Jieli He. « Development and comparison of UPLC-ESI-MS and RP-HPLC-VWD methods for determining microcystin-LR ». RSC Advances 11, n^o 37 (2021) : 23002–9. http://dx.doi.org/10.1039/d1ra03521e.

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UPLC-MS and HPLC-VWD methods were used together for MC-LR determination in a wide concentration range. UPLC-MS can be applied in trace MC-LR determination, whereas HPLC-VWD is more suitable for high concentration range detection.

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Rane, Shaligram S., Alkesh Ajameri, Rustom Mody et P. Padmaja. « Development and validation of RP-HPLC and RP-UPLC methods for quantification of erythropoietin formulated with human serum albumin ». Journal of Pharmaceutical Analysis 2, n^o 2 (avril 2012) : 160–65. http://dx.doi.org/10.1016/j.jpha.2011.11.006.

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Siddiqui, Khushnuma, et Bhavana Dubey. « Analytical Method Development and Validation of Ondansetron and Telmisartan in Tablet Dosage Form by RP-UPLC Method ». Journal of Drug Delivery and Therapeutics 12, n^o 4-S (25 août 2022) : 112–27. http://dx.doi.org/10.22270/jddt.v12i4-s.5548.

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The objective of the present analysis was the improvement of easy, exact as well as reproducible and precise verifies reversed phase Liquid Chromatography with High Performance [UPLC] assays for Telmisartan and Ondansetron. The chromatographic splitting up was done on Acuity UPLC BEH C 18 (50×2.1mm and1.7µm) column with gradient elution. The injection amount was 1µl and also the detection was performed at 214 nm by utilizing photo diode array detector. The evolved as well as a validated UPLC way of Telmisartan and Ondansetron in tablet dosage styles based on ICH tips was precise and accurate, therefore it may be utilized for equally evaluation scientific studies of medications. This process demonstrated the repeatability of outcomes with regard to accuracy, scientific studies, robustness, and then program - suitability problems. Keywords: UPLC, Ondansetron, chromatography, Telmisartan, accuracy, robustness

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Patel, D. M., B. Rana, S. Maru, A. J. Vyas, A. B. Patel, A. I. Patel et N. K. Patel. « Stability Indicating RP-UPLC Photo-Diode Array based Method for Determination of Edoxaban Tosylate ». Asian Journal of Organic & ; Medicinal Chemistry 5, n^o 3 (2020) : 273–76. http://dx.doi.org/10.14233/ajomc.2020.ajomc-p270.

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The objective of the current study was to develop a specific, precise, accurate and robust gradient stability indicating reversed-phase ultra performance liquid chromatography (RP-UPLC-PDA) assay method and validated for determination of edoxaban tosylate in API. Gradient separation was achieved on an acquity UPLC BEH C18 column (50 mm, 2.1 mm and 1.7 μm) column using mobile phase of acetoitrile:20 mM potassium dihydrogen phosphate, pH 3.0 ± 0.05 adjust with OPA at flow rate of 0.6 mL/min, the injection volume was 1 μL and the detection was carried out of 289 nm by using photodiode array detector. The drug was subjected to oxidation, hydrolysis, photolysis, and heat to apply stress condition. The method was linear in the drug concentration range of 100-300 μg/mL with correlation coefficient of 0.999. Degradation products produced as a result of stress studies did not interfere with detection of edoxaban tosylate and the assay, thus developed stability indicating method can be used for routine analysis in pharmaceutical industry.

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Chaithanya, Sunkara Mrunal, et Mukthinuthalapati Mathrusri Annapurna. « Stability indicating RP-UPLC method for the simultaneous determination of Atorvastatin and Amlodipine ». Research Journal of Pharmacy and Technology 12, n^o 10 (2019) : 4867. http://dx.doi.org/10.5958/0974-360x.2019.00843.6.

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Siva Madhu Chaitanya, Srinath Nissankararao et Satya Lakshmi Gandham. « A sort of validated Bioanalytical method developed for the estimation of Etoposide and Cisplatin in rat plasma by using two different advanced liquid chromatographic techniques like HPLC and UPLC and its application in bioequivalence studies ». International Journal of Research in Pharmaceutical Sciences 12, n^o 1 (13 janvier 2021) : 708–17. http://dx.doi.org/10.26452/ijrps.v12i1.4167.

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An easy, quick, precise, active and reproducible reverse method high performance liquid chromatography (RP-HPLC), as well as Ultra pressure liquid chromatography (UPLC) unique technique, was developed for the bioanalytical method of Etoposide and Cisplatin with Oxaplatin as an internal standard. Chromatographic analysis was performed using HPLC was Waters Alliance e-2695, and UPLC was Waters Acquity UPLC by using x-bridge phenyl 150x4.6mm, 3.5µ column and therefore the mobile phase containing 0.1% triethylamine and acetonitrile at a ratio out of 60:40 v/v. The flow rate was 1 ml/min, and analytes were detected at 283 nm employing a photodiode array detector at ambient temperature in both liquid chromatographic systems. The proposed biological method was proved in both HPLC and UPLC with USFDA guidelines. USP tailing is 1.1, 1.02 for etoposide and 1.16, 1.05 for Cisplatin in HPLC and UPLC. USP plate count is 4794, 3884 for Etoposide and 9289, 14487 for Cisplatin. The calibration curve under accumulation set of 5-100 ng/ml of etoposide and 10-200 ng/ml of Cisplatin in both HPLC and UPLC. The accuracy of low, middle and high-level quality control samples are taken in 50%, 100% and 150% levels. Stability study was administered altogether conditions are bench top, wet extract and auto sampler, freeze-thaw, short term stability and in long term stability. This is the advanced technique established to the straightforward, economical, suitable, precise, accurate and stable method for the analysis of Etoposide and Cisplatin and study of its stability and pharmacokinetic studies using rat plasma.

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Patel, A. J., N. K. Patel, A. J. Vyas, A. B. Patel et A. I. Patel. « RP-UPLC Stability Indicating Assay Method for Simultaneous Estimation of Dextromethorphan Hydrobromide and Chlorpheniramine Maleate in Tablet Dosage Form ». Asian Journal of Organic & ; Medicinal Chemistry 5, n^o 3 (2020) : 192–96. http://dx.doi.org/10.14233/ajomc.2020.ajomc-p269.

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RP-UPLC method was developed and validated for the determination of chlorpheniramine maleate and dextromethorphan hydrobromide in tablet dosage form. Reverse phase waters acquity UPLC BEH C18 (50 mm × 2.1 mm, 1.7 μm) column using isocratic mobile phase of 0.5 mL 0.1% TFA (trifluroacetic acid) in H2O:CH3CN (70:30 %v/v). The flow rate was 0.2 mL/min and 252 nm wavelength use for detection on PDA detector. The retention time of chlorpheniramine maleate was 1.2 min and 2.2 min for dextromethorphan hydrobromide. Chlorpheniramine maleate and dextromethorphan hydrobromide was subjected to stress conditions including acidic, alkaline, oxidation, photolysis and thermal degradation. The method was validated as per ICH guideline with respect to samples to specificity, precision, accuracy, linearity and robustness.

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Yang, Ming-Hui, Hsien-Yi Wang, Chi-Yu Lu, Wan-Chi Tsai, Po-Chiao Lin, Shih-Bin Su et Yu-Chang Tyan. « Proteomic Profiling for Peritoneal Dialysate : Differential Protein Expression in Diabetes Mellitus ». BioMed Research International 2013 (2013) : 1–15. http://dx.doi.org/10.1155/2013/642964.

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Peritoneal dialysis (PD) is an increasingly accepted modality of renal replacement therapy. It provides the advantages of having a flexible lifestyle, stable hemodynamics, and better preservation of residual renal function. To enhance our understanding of the peritoneal dialysate of diabetes mellitus (DM), peritoneal dialysate proteins were identified by two-dimensional gel electrophoresis (2DE) combined with reverse-phase nano-ultra performance liquid chromatography electrospray ionization tandem mass spectrometry (RP-nano-UPLC-ESI-MS/MS) followed by peptide fragmentation patterning. To validate the differential proteins, ELISA and Western blotting analyses were applied to detect candidate proteins that may be related to DM. We performed 2DE on the peritoneal dialysate samples, with detection of more than 300 spots. From this, 13 spots were excised, in-gel digested, and identified by RP-nano-UPLC-ESI-MS/MS. Ten of these showed significant differential expression between the DM and chronic glomerulonephritis (CGN) peritoneal dialysate samples. In this study, we conducted a comparative proteomic study on these two groups of dialysate that may provide evidence for understanding the different peritoneal protein changes. These proteins may not be new biomarkers; however, they may indicate a situation for possible drug treatment and can be the predictors of peritonitis for a validation study in the future.

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Madhavi, S., et A. Prameela Rani. « Development and validation of RP-UPLC method for simultaneous estimation of Cobicistat and Darunavir ». Research Journal of Pharmacy and Technology 10, n^o 12 (2017) : 4343. http://dx.doi.org/10.5958/0974-360x.2017.00796.x.

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Pudi, Rajesh, et Mukthinuthalapati Mathrusri. « New RP-UPLC method for The Simultaneous Determination of Haloperidol and Benzhexol in Tablets ». Research Journal of Pharmacy and Technology 12, n^o 6 (2019) : 2847. http://dx.doi.org/10.5958/0974-360x.2019.00479.7.

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Tang, Wanpei, Wu Li, Yuzhe Yang, Xue Lin, Lu Wang, Congfa Li et Ruili Yang. « Phenolic Compounds Profile and Antioxidant Capacity of Pitahaya Fruit Peel from Two Red-Skinned Species (Hylocereus polyrhizus and Hylocereus undatus) ». Foods 10, n^o 6 (25 mai 2021) : 1183. http://dx.doi.org/10.3390/foods10061183.

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Pitahaya peel is a good source of bioactive polyphenols. However, the bound phenolics and their antioxidant activity remain unclear. The bound phenolics of pitahaya peel from two red-skinned species with red pulp (RP) and white pulp (WP) were released with different methods (acid, base, and composite enzymes hydrolysis). The results revealed that base hydrolysis was the most efficient method for releasing the bound phenolics from RP (11.6 mg GAE/g DW) and WP (10.5 mg GAE/g DW), which was 13.04-fold and 8.18-fold for RP and 75.07-fold and 10.94-fold for WP compared with acid hydrolysis and enzymatic hydrolysis, respectively. A total of 37 phenolic compounds were identified by UPLC-TOF/MS with most chlorogenic acid, caffeic acid, ferulic acid and p-coumaric acid in RP, whereas chlorogenic acid, caffeic acid, ferulic acid, rutin and isoquercitrin were the main compounds in WP. Regardless of the hydrolysis method, the extracts having the highest phenolic content showed the strongest antioxidant activities. The work shows that hydrolysis methods have a significant effect on the release of phenolics, and the contents of major characteristic bound phenolic compounds are related to the ecological type of pitahaya.

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J, David Blessing Rani, et Asha Deepti C. « STABILITY INDICATING METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF PREGABALIN AND ETORICOXIB IN BULK AND TABLET DOSAGE FORM BY UPLC ». YMER Digital 21, n^o 07 (18 juillet 2022) : 581–603. http://dx.doi.org/10.37896/ymer21.07/46.

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A simple, accurate and precise reverse phase ultra-performance liquid chromatography method was developed and validated for simultaneous estimation of Pregabalin and Etoricoxib in formulations as well as in pure form. The developed method was shown acceptable separation of pregabalin and Etoricoxib. The retention times for Pregabalin and Etoricoxib were 1.134 min. & 1.535 min. respectively. The limits of detection and quantification were obtained from regression equations and observed to be 0.85ppm and 0.54ppm for Pregabalin, 2.58 and 1.62ppm for Etoricoxib, respectively. Degradation studies of the tablet dosage form under stress conditions of acid, base, oxidation , temperature, water, UV light indicated that the method was particular with no interferences from any of the potential impurities that could form over the shelf life. The new developed RP-UPLC method which was sensitive, accurate stability indicating and fast, for active pharmaceutical ingredients and dosage forms. Key words: Pregabalin, Etoricoxib, Simultaneous, Reverse Phase - UPLC

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Noorbasha, Khaleel, et K. Abdul Rahaman S. « STABILITY-INDICATING RP-UPLC METHOD FOR SIMULTANEOUS DETERMINATION OF DOLUTEGRAVIR AND RILPIVIRINE IN BULK AND PHARMACEUTICAL DOSAGE FORM ». INDIAN DRUGS 56, n^o 10 (28 octobre 2019) : 42–49. http://dx.doi.org/10.53879/id.56.10.11796.

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Specific stability-indicating reversed-phase ultra-performance liquid chromatography (UPLc) method has been developed and validated for the simultaneous quantification of dolutegravir and rilpivirine in bulk drugs and pharmaceutical dosage forms. the optimized conditions for the developed UPLc method are Sb c8 column (100 x 3 mm, 1.8 mm) maintained at 30°c with mobile phase consisting of 0.1% ortho phosphoric acid and acetonitrile in the ratio 55:45%v/v in isocratic mode at flow rate of 1 mL/min and detection wavelength 260 nm. the retention times of dolutegravir and rilpivirine were found to be 1.25 min, and 1.69 min with linearity in the concentration ranges from 12.5 – 75.0 µg/mL and 6.25 – 37.5 µg/mL, respectively. the mean percentage recoveries of dolutegravir and rilpivirine were found to be 99.04 - 99.79 % and 99.20 - 99.92 %, respectively. the percent relative standard values were less than 2.0 at all the levels, indicating satisfactory accuracy and precisiom. the robustness was found to meet the acceptance criteria. the stress study against qualified working standards of dolutegravir and rilpivirine indicated that the developed UPLc method was stability- indicating, conducted as per ICH requirements.

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Amir, Mohammad, Puneet Narula et Farzana Bano. « Analytical Techniques for the Analysis of Lopinavir and Ritonavir in Pharmaceutical Dosage Form and Biological Matrices : A Review ». Current Pharmaceutical Analysis 18, n^o 4 (28 février 2022) : 380–414. http://dx.doi.org/10.2174/1573412918666211217145200.

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Background: Lopinavir and Ritonavir are protease inhibitor type of anti-retroviral drugs. Both are used for the treatment of HIV/AIDS. This paper reviews many analytical methods for the analysis of LPV and RTV in pharmaceutical formulations (tablet, capsule, syrup, and bulk) and biological fluids (human plasma, serum, cerebrospinal fluid, rat plasma, and human hair). Objective: The study aims to summarize various analytical techniques, such as chromatography and spectrophotometry, and also hyphenated techniques, such as LC-MS/MS and UPLC-MS, for the analysis of Lopinavir and Ritonavir. Method: The review deals with comprehensive details regarding the type of various analytical techniques, such as spectroscopy (UV), chromatography (RP-HPLC, HPTLC, UPLC), and hyphenated techniques, i.e., LC-MS/MS and UPLC-MS, for the analysis of lopinavir and ritonavir. These techniques are either explored for the quantification and detection of metabolite or for stability studies of the LPV and RTV. Conclusion: The studies presented revealed that the HPLC technique along with spectroscopy have been most widely used for the analysis. Out of the developed methods, hyphenated UPLCMS and LC-MS are very sensitive and help in the easy estimation of drugs compared to other techniques. This review may provide comprehensive details to the researchers working in the area of analytical research of LPV and RTV.

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Vorkas, Panagiotis A. « Expanding lipidome coverage using MS/MS-aided untargeted data-independent RP–UPLC–TOF–MSE acquisition ». Bioanalysis 10, n^o 5 (mars 2018) : 307–19. http://dx.doi.org/10.4155/bio-2017-0249.

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Basha, D. Mahaboob, G. Venkata Reddy, T. Shobha Rani, E. Susithra et Rajasekhar Chekkara. « RP-UPLC-MS Assay Method for Eltrombopag : Application in Pharmaceuticals, Human Plasma and Urine Samples ». Asian Journal of Chemistry 27, n^o 12 (2015) : 4615–19. http://dx.doi.org/10.14233/ajchem.2015.19252.

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Dadi, Vamsi, et Gummadi Sowjanya. « Novel Method Development, Validation and Forced Degradation Studies for the Concurrent Determination of Lamivudine, Tenofovir Disoproxil Fumarate and Doravirine in Active Pharmaceutical Ingredient and Formulation using RP-UPLC ». Oriental Journal Of Chemistry 38, n^o 6 (30 décembre 2022) : 1460–66. http://dx.doi.org/10.13005/ojc/380618.

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The main objective of proposed method is to develop, validate & to perform the forced degradation studies for the simultaneous quantification of lamivudine, doravirine and tenofovir in active pharmaceutical ingredient (API) and formulation using reverse phase ultra-performance liquid chromatography (RP-UPLC). The estimation was performed using HSS C18 (100mm×2.1mm,1.8µ)column with acetonitrile and 0.1 % ortho phosphoric acid (OPA) (35:65) as mobile phase ran in isocratic mode at rate of flow 0.3ml/min. The column temperature maintained at 30°C and detection wavelength used was 260nm. The developed method validated as per ICH guidelines. Method obeyed Beer’s law in the range of concentration of 37.5µg/ml – 225µg/ml, 37.5µg/ml – 225µg/ml and 12.5µg/ml – 75µg/ml for lamivudine, tenofovir and doravirine respectively. The method is stable when exposed to different stressed conditions with less degradation. For regular analysis of estimate of lamivudine, tenofovir, and doravirine in tablet formulation, this UPLC method can be employed

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Lang, Lang, Zhaorui Meng, Lan Sun, Wei Xiao, Longshan Zhao et Zhili Xiong. « Intergrated metabonomic study of the effects of Guizhi Fuling capsule intervention on primary dysmenorrheal using RP-UPLC-MS complementary with HILIC-UPLC-MS technique ». Biomedical Chromatography 32, n^o 2 (2 octobre 2017) : e4093. http://dx.doi.org/10.1002/bmc.4093.

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Górnaś, Paweł, Inga Mišina, Silvija Ruisa, Edgars Rubauskis, Gunārs Lācis et Dalija Segliņa. « Composition of tocochromanols in kernels recovered from different sweet cherry (Prunus avium L.) cultivars : RP-HPLC/FLD and RP-UPLC-ESI/MSn study ». European Food Research and Technology 240, n^o 3 (12 novembre 2014) : 663–67. http://dx.doi.org/10.1007/s00217-014-2382-x.

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Chen, Fuxin, Xiaoxian Ma, Chuangqian Chen, Kanshe Li, Suying Chen, He Wen et Pin Gong. « A Validated Chiral-RP-UPLC-MS/MS Method for the Enantiomeric Detection of Rivaroxaban In vitro ». Current Pharmaceutical Analysis 15, n^o 4 (19 mars 2019) : 305–11. http://dx.doi.org/10.2174/1573412914666180409145403.

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Background: Rivaroxaban is the first oral, selective direct FXa inhibitor with rapid onset of action and its biological toxicity may be related to the enantiomer. </P><P> Objective: The aim of the current study was to develop and validate a precise, accurate, and specific direct Chiral-RP-UPLC-MS/MS method for the enantiomeric separation and detection of rivaroxaban and its enantiomer. Methods: The present study screened various conditions of chromatographic and mass spectra, including chromatographic column model, flow velocity, phase ratio, column temperature, and collision energy, parent/daughter ion pairs, etc. Try to match the chromatographic and mass spectrometric conditions. Results: Good Rs (Rs>2.5) was achieved on a Chiralpak IC column (4.6 × 250 mm, 5µm) using H2O:acetonitrile (10:90) as mobile phase at 25 oC column temperature. The rate of flow was set at 0.4 ml/min and enantiomers were detected by triple-quadruple tandem mass spectrometry using positive electrospray ionization (ESI) with MRM transitions of m/z 436.07>144.95. The cone voltage and collision energy were kept at 48 V and 28 eV, respectively. The limit of detection and quantification of (S)- rivaroxaban were 0.39 and 1.30 ng/ml, respectively. This method was validated and found to be selective, precise, accurate, linear and robust for the quantitative determination of chiral impurities. It is also a good application for the blood samples analysis in vitro. Conclusion: Chiral-RP-UPLC-MS/MS method has entirely detected (S)-rivaroxaban and its (R)- enantiomer in very low concentration and complex matrix directly, especially for blood samples.

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Semreen, Mohammad, Hasan Alniss, Muath Mousa et Hassan Aboul-Enein. « Quick and Sensitive UPLC-ESI-MS/MS Method for Simultaneous Estimation of Sofosbuvir and Its Metabolite in Human Plasma ». Molecules 24, n^o 7 (3 avril 2019) : 1302. http://dx.doi.org/10.3390/molecules24071302.

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A simple, fast and highly sensitive RP-UPLC-MS/MS method was developed and validated for the simultaneous determination of sofosbuvir (SR) and its metabolite GS331007 in human plasma using ketotifen as an internal standard (IS). The separation was achieved on Acquity UPLC BEH C18 (50 × 2.1 mm, i.d. 1.7 µm, Waters, USA) column using acetonitrile:5 mM ammonium formate:0.1% formic acid (85:15:0.1% v/v/v) as a mobile phase at a flow rate of 0.35 mL/min in an isocratic elution. The Xevo TQD UPLC-MS/MS was operated under the multiple-reaction monitoring mode using positive electrospray ionization. Extraction with dichloromethane was used in the sample preparation. Method validation was performed as per the Food and Drug Administration (FDA) guidelines and the calibration curves of the proposed method were found to be linear in the range of 1–1000 ng/mL for SR and in the range of 10–1500 ng/mL for its metabolite (GS331007) with an elution time of 1.83 min. All validation parameters were within the acceptable range according to the bioanalytical methods validation guidelines. Furthermore, the obtained results of matrix effects indicate that ion suppression or enhancement from human plasma components was negligible under the optimized conditions. The proposed method can be applied in high-throughput analysis required for pharmacokinetic and bioequivalence studies in human samples.

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Rane, Shaligram S., Alkesh Ajameri, Rustom Mody et P. Padmaja. « Development and validation of RP-HPLC and RP-UPLC methods for quantification of parathyroid hormones (1-34) in medicinal product formulated with meta-cresol ». Journal of Pharmaceutical Analysis 2, n^o 2 (avril 2012) : 136–42. http://dx.doi.org/10.1016/j.jpha.2011.12.001.

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Górnaś, Paweł, Iveta Pugajeva et Dalija Segliņa. « Seeds recovered from by-products of selected fruit processing as a rich source of tocochromanols : RP-HPLC/FLD and RP-UPLC-ESI/MSn study ». European Food Research and Technology 239, n^o 3 (21 mai 2014) : 519–24. http://dx.doi.org/10.1007/s00217-014-2247-3.

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Younes, Husam. « Development of RP-UPLC method for the assay and stability evaluation of letrozole in pharmaceutical emulgels ». Qatar Foundation Annual Research Forum Proceedings, n^o 2013 (novembre 2013) : BIOP 012. http://dx.doi.org/10.5339/qfarf.2013.biop-012.

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Vijaya Bhaskara Reddy, Tummala, Nallagari Sowjanya Reddy, Sanivarapu Ravi Prakash Reddy, Golkonda Ramu et Chintala Rambabu. « Optimized and validated stability indicating RP-UPLC method for the determination of famotidine in pharmaceutical formulations ». Journal of Pharmacy Research 6, n^o 8 (août 2013) : 865–69. http://dx.doi.org/10.1016/j.jopr.2013.08.003.

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Gupta, H., M. Aqil, R. K. Khar, A. Ali, A. Sharma et P. Chander. « Development and Validation of a Stability-Indicating RP-UPLC Method for the Quantitative Analysis of Sparfloxacin ». Journal of Chromatographic Science 48, n^o 1 (1 janvier 2010) : 1–6. http://dx.doi.org/10.1093/chromsci/48.1.1.

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Cueto-Rojas, H. F., N. O. Pérez, G. Pérez-Sánchez, I. Ocampo-Juárez et E. Medina-Rivero. « Interferon-α 2b quantification in inclusion bodies using Reversed Phase-Ultra Performance Liquid Chromatography (RP-UPLC) ». Journal of Chromatography B 878, n^o 13-14 (avril 2010) : 1019–23. http://dx.doi.org/10.1016/j.jchromb.2010.02.016.

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Prashanth, Kudige N., Kanakapura Basavaiah, Madihalli S. Raghu, Cijo M. Xavier et Kanakapura B. Vinay. « Determination of Flunarazine Dihydrchloride in Bulk Drug and Tablets by RP-UPLC : A Stability-Indicating Assay ». Proceedings of the National Academy of Sciences, India Section A : Physical Sciences 83, n^o 2 (10 avril 2013) : 79–88. http://dx.doi.org/10.1007/s40010-013-0068-6.

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Kerai, Jayshri R., Amitkumar J. Vyas, Bhupatsinh Vihol, Parth Patel et Ashok Patel. « DAD Based Stability Indicating RP-UPLC Method for Simultaneous Determination of Olmesartan Medoxomil and Amlodipine Besylate ». Pharmaceutical Chemistry Journal 52, n^o 11 (février 2019) : 959–64. http://dx.doi.org/10.1007/s11094-019-01933-0.

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d’Oliveira, Giulio D. C., Andréa R. Chaves et Caridad N. Pérez. « Development and Analytical Validation of the Methodology for Vitamins in Tablets by Ultra-Performance Liquid Chromatography ». Journal of Chromatographic Science 57, n^o 10 (14 octobre 2019) : 881–91. http://dx.doi.org/10.1093/chromsci/bmz070.

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Abstract In the present study, we developed a reliable and robust chromatographic method for the quantification of multivitamins in tablet samples by ultra-performance liquid chromatography (UPLC) with photodiode array detection. The vitamins nicotinamide, pyridoxine, riboflavin, and thiamin were analyzed and quantified in a total analysis time of 2.5 minutes, using hydrophilic interaction liquid chromatography stationary phase. Tocopherol acetate and cyanocobalamin were analyzed and quantified in a total analysis time of 2.5 minutes, using reversed-phase (RP)-UPLC. The analysis time reported here is lower than that of similar methods reported in the literature for single vitamin determination. The method linearity exhibits a good correlation coefficient (R2 = 0.998) with the relative residual standard deviation in the acceptable limit of 2.0%. The developed methods were validated, and the results demonstrated that the proposed analytical method showed to be selective, sensitive, accurate, and robust for the quantification of evaluated vitamins in multivitamin tablets. The work was fully developed in the quality control laboratory of a pharmaceutical industry in the Agroindustrial District of Anápolis (DAIA, Goiás, Brazil), where the product is manufactured.

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Dabhi, Batuk, Bhavesh Parmar, Nitish Patel, Yashwantsinh Jadeja, Madhavi Patel, Hetal Jebaliya, Denish Karia et A. K. Shah. « A Stability Indicating UPLC Method for the Determination of Levofloxacin Hemihydrate in Pharmaceutical Dosage Form : Application to Pharmaceutical Analysis ». Chromatography Research International 2013 (19 juin 2013) : 1–5. http://dx.doi.org/10.1155/2013/432753.

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A reliable and sensitive isocratic stability indicating RP-UPLC method has been developed and validated for quantitative analysis and content uniformity study of levofloxacin hemihydrate in tablets. An isocratic method for analysis of levofloxacin hemihydrate was archived on ACQUITY UPLC BEH C18 (100*2.1) mm particle size 1.7 μ columns within shorter runtime of 4 min with a flow rate of 0.400 mL/min and using a photodiode array detector to monitor the eluate at 294 nm. The mobile phase consisted of acetonitrile-buffer (23 : 77 v/v), (buffer: 20 mM K2HPO4 + 1 mL triethylamine in 1 L water, pH=2.50 by orthophosphoric acid). Response was a liner function of drug concentration in the range of 0.5–80 μg/mL (r2=0.999) with a limit of detection and quantification of 0.1 and 0.5 μg/mL, respectively. Accuracy (recovery) was between 99.77% and 101.55%. The drug was subjected to oxidation, hydrolysis, photolysis, and thermal degradation. Degradation products resulting from the stress studies did not interfere with the detection of levofloxacin hemihydrate, and the assay is stability indicating.

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Priya, Dandamudi S., Shivakumar Gubbiyappa et Vasanthi Rangapuram. « A Novel Stability Indicating Reversed Phase Ultra Performance Liquid Chromatography Method for Estimation of Asciminib its Bulk and Tablet Formulation ». INTERNATIONAL JOURNAL OF PHARMACEUTICAL QUALITY ASSURANCE 13, n^o 04 (1 septembre 2022) : 490–95. http://dx.doi.org/10.25258/ijpqa.13.4.23.

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The key objective of the proposed study was to creat and validate an economical, perceptive, specific, reliable and simple reversed phase ultra-performance liquid chromatography (RP-UPLC) method with better response was anticipated for the investigation of asciminib bulk powder and its tablet form. UPLC system (WATERS, Model-2695) connected with PDA (Model-2996) detector was opted to made the present method. To separate asciminib proficiently, method conditions such as C18 column (50 x 4.6 mm, 1.7 m), mobile system of trifluoro aceticacid (TFA) in water (0.1%) and acetonitrile in 75:25 v/v, 0.3 mL/min flow rate and 260 nm wavelength were used as optimized chromatographic conditions. The anticipated method was validated by the ICH specifications. The retention time of asciminib was noticed at 0.925 minute with good efficiency, respectively. Linearity was noticed for concentrations ranging fom 5 to 30 μg/mL of asciminib with R2 value of 0.999. The %RSD of both system and method precision was assessed in the range of 0.49 to 0.86. The percentage recovery of asciminib was in the range of 100.06–100.6%. The logarithm of the odds (LoD) and limit of quantitation (LoQ) of asciminib determined to be 0.23 and 0.69 μg/mL correspondingly. The results confirmed that the projected technique was economical, simple, responsive and precise. Exploration of asciminib under various FD environments confirms the stability representing the nature of the stated method. The proposed UPLC method is extremely valuable in the separation and estimation of asciminib.

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Ponnekanti, Krishnaphanisri, et Raja Sundararajan. « DEVELOPMENT AND VALIDATION OF NEW RP-UPLC METHOD FOR THE DETERMINATION OF CEFDINIR IN BULK AND DOSAGE FORM ». International Journal of Pharmacy and Pharmaceutical Sciences 10, n^o 1 (1 janvier 2018) : 178. http://dx.doi.org/10.22159/ijpps.2018v10i1.23256.

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Objective: The objective of the study was to develop and validate a new rapid and sensitive reverse phase ultra-performance liquid chromatographic (RP-UPLC) method for determination of cefdinir in bulk drug and dosage form.Methods: Separation was achieved with an Acquity SB C18 (100 × 2 mm) 1.8μm column with an isocratic mobile phase containing a mixture of orthophosphoric acid and acetonitrile (60:40 v/v) and pH adjusted to 2.8. The flow rate of the mobile phase was 0.3 ml/min with a column temperature of 30 °C and detection wavelength at 285 nm.Results: The method was validated with respect to linearity, accuracy, precision, detection limits, robustness and specificity. The precision of the results, stated as the relative standard deviation was below 1.5%. The calibration curve was linear over a concentration range from 25 to 150μg/ml with a correlation coefficient of 0.9993. The accuracy of the method demonstrated at three levels in the range of 50%, 100% and 150% of the specification limit. The recovery of cefdinir was found to be in the range of 98 to 102%, whereas the detection limits were found to be 0.17 and 0.51µg/ml. Forced degradation study was carried out under acidic, alkaline, oxidative, photolytic and thermal conditions to prove the stability-indicating ability of the developed UPLC method.Conclusion: The developed method was validated with respect to linearity, accuracy, precision limit of detection and quantification, robustness and specificity. The method was applied successfully for the determination of cefdinir in tablets.

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Feng, Tao, Yang Wu, Zhiwen Zhang, Shiqing Song, Haining Zhuang, Zhimin Xu, Linyun Yao et Min Sun. « Purification, Identification, and Sensory Evaluation of Kokumi Peptides from Agaricus bisporus Mushroom ». Foods 8, n^o 2 (29 janvier 2019) : 43. http://dx.doi.org/10.3390/foods8020043.

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Agaricus bisporus can enhance the umami and salty taste in chicken soup, and also has a high protein content, which indicates that there might be some kokumi taste compounds in this mushroom. Therefore, through ultrafiltration, gel permeation chromatography (GPC), and reverse phase-high performance liquid chromatography (RP-HPLC), some peptides in fresh Agaricus bisporus mushroom were isolated. Then, these peptides were identified by sensory evaluation and ultra performance liquid chromatography (UPLC) coupled quadruple time of flight mass spectrometry (Q-TOF-MS). The sensory evaluation results showed that the addition of aqueous extract isolated from Agaricus bisporus to model chicken broth did enhance chicken broth’s complexity, mouthfulness, and palatability. UPLC-Q-TOF-MS analysis found that Gly-Leu-Pro-Asp (Mw = 399.99) and Gly-His-Gly-Asp (Mw = 383.99) might act as key molecules to cause kokumi taste. In order to verify the kokumi taste of the above two peptides, they were synthesized by solid-phase synthesis and the taste properties of these two peptides were further characterized by descriptive sensory evaluation and taste intensity tests. This work indicated that it was feasible to produce kokumi peptides from Agaricus bisporus.

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Kumar, M. Narendra, V. Krishna Reddy, Hemant Kumar Sharma, T. Kaleemullah, T. Chandra Sekhar Reddy, G. Thirupathi Reddy, N. Sreenivas et Goutam Sen. « A Simple and Sensitive RP-UPLC Method for the Simultaneous Determination of N-Hydroxybenzotriazole, Cinchonidine and 1,3-Dicyclohexyl Urea Contents in Fosinopril Sodium Drug Substance ». E-Journal of Chemistry 9, n^o 4 (2012) : 2058–67. http://dx.doi.org/10.1155/2012/780247.

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A simple and sensitive reverse phase ultra performance liquid chromatography (RP-UPLC) method has been developed, optimized and validated for the simultaneous determination of N-Hydroxybenzotriazole (HOBt), Cinchonidine and 1,3-Dicyclohexyl urea (DCU) contents at low levels in fosinopril sodium drug substance. Efficient chromatographic separation was achieved on Acquity UPLC HSS C18column, 100 mm long with 2.1 mm i.d., 1.8 µm particle diameter, thermo stated at 30°C. Gradient elution involving binary mixture of potassium dihydrogen orthophosphate (0.01M, pH:3.0±0.05 withortho-phosphoric acid) and acetonitrile at a flow rate of 0.10 mL min-1has been used. The analytes were monitored by photodiode array (PDA) detector set at 205 nm. The drug substance was subjected to stress conditions of hydrolysis, oxidation, photolysis, thermal and humidity degradation. The method was validated for specificity, sensitivity, linearity, precision, accuracy and solution stability. The limit of detection (LOD) and limit of quantification (LOQ) for HOBt, Cinchonidine and DCU were in the range of 0.85-3.52 ppm and 2.57-10.67 ppm, respectively. The average recoveries for HOBt, Cinchonidine and DCU are in the range of 98.1% to 102.6%. The method can be used for the routine quality control analysis of fosinopril sodium drug substance.

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Raja, K. Durga, V. Saradhi Venkata Ramana, K. Raghu Babu, B. Kishore Babu, V. Jagadeesh Kumar, K. S. R. Pavan Kumar et Hemant Kumar Sharma. « Simultaneous and Trace Level Determination of Six Potential Impurities by UPLC-ESI-MS/MS in Antiarrhythmic Drug : Dronedarone Hydrochloride ». Asian Journal of Chemistry 32, n^o 5 (2020) : 1183–90. http://dx.doi.org/10.14233/ajchem.2020.22588.

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Development and validation of six potential impurities by ultra performance liquid chromatography electro spray ionization tandem mass (UPLC-ESI-MS/MS) method for dronedarone hydrochloride drug was accomplished coherent with ICH guidelines. Successful chromatographic separation of dronedarone with its six impurities was attained by using gradient elution mode on RP-UPLC column using three pump mode system of 0.1 % formic acid in water as mobile phase A, methanol as the mobile phase B and solvent mixture of methanol, acetonitrile and water in the ratio of 65:30:5 v/v/v as the mobile phase C. Chromatographic conditions were set as 0.3 mL min-1 flow rate at the column temperature of 45 °C with the injection volume 2 μL. Briefly, the method enabled quantitation of six impurities with high accuracy (recovery > 90 %) and precision (% RSD < 5.0),within the ranges of 0.18-2.82 μg g-1. The regression (r) for each impurity over a range was > 0.99. The detection limit and quantitation limit of impurities were set at 0.09 and 0.18 μg g-1, respectively. The performed validation tests proved the suitability of the method for its intended purposes.

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Shitole, Suresh, Mukund Gurjar, Mahesh Shah, Srikant Pimple, Gobardhan Bal et Rahul Patel. « Development and Validation of Stability-Indicating RP-UPLC Method for Simultaneous Determination of Related Substances of S(−)Amlodipine and S(−)Metoprolol Succinate in Fixed Dose Combination Tablet Dosage Form ». Chromatography Research International 2014 (20 octobre 2014) : 1–9. http://dx.doi.org/10.1155/2014/874587.

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A novel, rapid, accurate, sensitive, precise, and stability-indicating reverse-phase ultra-performance liquid chromatographic (RP-UPLC) method was developed and validated for determination of related substances of S(−)Amlodipine and S(−)Metoprolol Succinate in fixed dose combination tablet dosage form. The chromatographic separation was achieved with the use of Acquity UPLC HSS T3, 1.8 μm, 2.1 × 100 mm analytical column at 45°C employing a gradient elution. Mobile phase consisting of mobile phase-A (solution containing 5.0 gm of sodium dihydrogen phosphate monohydrate per liter of water and Acetonitrile in the ratio of 95 : 5) and mobile phase-B (Acetonitrile) was used at a flow rate of 0.5 mL min−1 with injection volume of 10 μL and the detection was done at 232 nm using UV detector. The retention times of S(−)Metoprolol Succinate and S(−)Amlodipine were found to be 2.8 minutes and 8.1 minutes, respectively. During method validation all the parameters were evaluated as per ICH guidelines, which remained well within acceptable limits. This method can be used for the estimation of related substances of S(−)Amlodipine and S(−)Metoprolol Succinate in fixed dose combination tablet dosage form.

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