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ISSN 2063-5346
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A NOVEL RP-UPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS DETERMINATION OF VONOPRAZAN AND AMOXICILLIN IN FIXED DOSAGE COMBINATION

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Sridhar Bonam, T. Siva Rao, K. Rama Srinivas, Pallapati Suman, Sivaganesh Tene, K. Mariadas
» doi: 10.31838/ecb/2023.12.s3.424

Abstract

Background and Aim:The present day scenario, the dualdrug therapy is more effective than singledose therapy due to reduction of side effects at minimum dosage. Hence, The present research aims to create a novel, fast, easy, sensitive, and one-of-a-kind ultra-performance liquid chromatographic (UPLC) stability-indicating approach for the dosage-simultaneous assessment of amoxicillin and vonoprazan. Materials and Methods: An efficient chromatographic separation was accomplished with a flow rate of 0.5 ml/min, a BEH-C18 column, and a mobile phase consisting of 0.1% H3PO4 and CH3CN (50:50 v/v). The adapted elution process was isocratic and separation was completed within 6 minutes of run time under ambient temperature conditions at 230nm. Forced degradation studies and method validation were undertaken in accordance with the norms of the ICH. Results and Discussion:The linearity of Amoxicillin and Vonoprazan was studied at concentrations of 62.5–375µg/ml and 2.5–15µg/ml, and the correlation coefficient (r2 ) for both drug were found to be greater than 0.99. LOD values of Amoxicillin and Vonoprazan were determined at 0.75µg/ml and 2.5µg/ml as well as 0.03µg/ml and 0.1µg/ml being the LOQ values. For Amoxicillin, the obtained percentage recovery values lay between 99.7% and 100.7%, and for Vonoprazan, between 100.1% and 100.4%. Studies on forced degradation revealed a clear resolution of the analyte peaks. Conclusion: Using a new, rapid, sensitive, and affordable RP-UPLC approach, the simultaneity of Vonoprazan and Amoxicillin determination in Fixed Dose combination was effectively developed and validated.

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