Method Development and Validation for Simultaneous Estimation of Metformin Hydrochloride and Empagliflozin in Bulk and Pharmaceutical Dosage Forms by RP-HPLC

Volume 23 No 8 (2025)

Pamu Jacob , Gope Edward Raju , Doonaboyina Raghava , Kavala Nageswara Rao

DOI: 10.48047/nq.2025.23.8.nq25016

Abstract

This study aims to develop and validate a simple, accurate, and precise RP-HPLC method for the simultaneous estimation of Metformin Hydrochloride and Empagliflozin in bulk and tablet dosage forms. Metformin and Empagliflozin are commonly prescribed together for the management of type 2 diabetes mellitus. The developed method utilizes a C18 column with a mobile phase comprising phosphate buffer and acetonitrile under isocratic conditions. Validation was carried out as per ICH Q2 (R1) guidelines for parameters including linearity, precision, accuracy, limit of detection (LOD), and limit of quantification (LOQ). The method was successfully applied to commercial formulations, demonstrating its suitability for routine quality control.

Keywords

Metformin Hydrochloride, Empagliflozin, RP-HPLC, Method Validation, Simultaneous Estimation, Type 2 Diabetes Mellitus

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