RP-HPLC Method Development and Validation of a Stability-Indicating Method for the Estimation of Metformin Hydrochloride and Glibenclamide in Bulk and Tablet Dosage Forms

Volume 23 No 8 (2025)

Kavali Gayathri, Gope Edward Raju, Doonaboyina Raghava, Kavala Nageswara Rao

DOI: 10.48047/nq.2025.23.8.nq25010

Abstract

Antidiabetic drugs like Metformin and Glibenclamide are frequently prescribed in combination for effective management of Type 2 Diabetes Mellitus. Ensuring the stability of these drugs during formulation and storage is essential to maintain efficacy and safety. This study aims to develop and validate a stability-indicating RP-HPLC method for simultaneous estimation of Metformin Hydrochloride and Glibenclamide in bulk and tablet dosage forms. The method involves subjecting drug substances to various stress conditions (acidic, basic, oxidative, thermal) and establishing a validated analytical procedure that can detect degradation products. The method will be validated as per ICH Q2(R1) guidelines.

Keywords

Metformin Hydrochloride, Glibenclamide, RP-HPLC, Stability-indicating method, Method validation, ICH Q2(R1)

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