Development and validation of UV spectrophotometric method for Simultaneous estimation of Empagliflozin and Metformin hydrochloride in bulk drugs and combined dosage forms

Research Article

N.Padmaja, Mulagiri Sharath Ba

Abstract

Two simple, precise and economical UV spectrophotometric methods have been developed for the simultaneous estimation of Empagliflozin and Metformin hydrochloride in bulk and pharmaceutical dosage forms. Method A is simultaneous equation method (Vierodt’s Method), which is based on measurement of absorption at 272nm and 234nm i.e. λmax of Empagliflozin and Metformin hydrochloride respectively. Method B is Absorbance ratio (Qanalysis method) which is based on measurement of absorption at wavelength of 254nm and 226nm i.e. iso absorptive point of Empagliflozin and Metformin hydrochloride and λmax of Empagliflozin respectively. Linearity was observed in the concentration range of 5-25μg/ml for Empagliflozin and 2-12μg/ml for Metformin hydrochloride. The accuracy of methods was assessed by recovery studies and was found to be within range of 98.99-101.12% for both Empagliflozin and Metformin hydrochloride. The developed methods were validated with respect to linearity, accuracy (recovery), and precision. The results were validated statistically as per ICH Q2 R1 guideline and were found to be satisfactory.

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