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ISSN 2063-5346
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Stability Indicating Rp-Uplc Method Development And Validation For The Simultaneous Estimation Of Metformin Hydrochloride, Saxagliptin And Dapagliflozin In Their Bulk And Pharmaceutical Dosage Forms

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Upender Rao Eslawath1, , Kannappan N1, Venkateshwarlu L2 and Anton Smith A1
» doi: 10.48047/ecb/2023.12.si12.015

Abstract

A simple, rapid and sensitive method is developed for the simultaneous estimation of Metformin HCl, Saxagliptin and Dapagliflozin in their bulk and pharmaceutical dosage forms by RP-UPLC. The solubility studies of the drugs were carried out at 250C using distilled water, methanol, acetonitrile and buffers as solvents. The analysis of drugs is carried out using Acquity UPLC BEH C18 column (10mm × 2.1mm ID, 1.7µm) at 280nm wavelength with mobile phase composition of 0.02M phosphate buffer pf pH 4.5 and acetonitrile in the ratio of 70:30. The retention time for Metformin HCl, Saxagliptin and Dapagliflozin is found to be 2.601, 4.329 and 5.238 respectively. The developed method is validated for various parameters like linearity, accuracy, precision, robustness, specificity, and system suitability as per ICH guidelines. The stability of the drugs is assessed by various stress conditions like acid, alkali, peroxide, photolytic and thermal degradation. All the results were found to be within the acceptance limits. Hence the present method can be conveniently adopted for the estimation of Metformin HCl, Saxagliptin and Dapagliflozin.

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