Multipurpose chromatographic method for concurrent stability study of metformin, dapagliflozin, and glimepiride using integrated principles of RGB12 and white analytical chemistry

Abstract Background The research develops a novel multipurpose chromatographic method for concurrent stability analysis of metformin hydrochloride (MH), dapagliflozin propanediol monohydrate (DPM), and glimepiride (GP). It addresses the need for a stability-indicating HPTLC method for simultaneous estimation of these drugs in a combined dosage form, crucial for treating type 2 diabetes mellitus. Objectives The objectives of the proposed research are to develop and validate a stability-indicating HPTLC method for simultaneous quantification of MH, DPM, and GP in pharmaceutical dosage form. The study aims to conduct forced degradation studies under various stress conditions and optimize the HPTLC method development using an AQbD approach. Method The proposed research employs a high-performance thin-layer chromatography method optimized using an analytical quality by design approach. The method utilizes statistical tools like Plackett–Burman design and minimum run resolution IV design to optimize critical parameters. It includes forced degradation studies under various stress conditions and validation according to ICH Q2 (R2) guidelines. The method is applied to analyze marketed formulations containing MH, DPM, and GP. Results The developed HPTLC method demonstrated high accuracy, precision, and sensitivity for simultaneous estimation of MH, DPM, and GP. The method effectively separated degradation products from parent compounds under various stress conditions, proving its stability-indicating nature. It showed good linearity, low LOD and LOQ values, and high recovery rates. The method successfully analyzed marketed formulations, with results in good agreement with labeled claims. Additionally, the method outperformed previously published RP-HPLC methods in terms of environmental sustainability and operational efficiency. Conclusions The developed HPTLC method provides a robust, environmentally friendly, and efficient tool for simultaneous stability analysis of MH, DPM, and GP. It outperforms existing methods in terms of analytical quality, sustainability, and operational efficiency.