ANAYTICAL METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF DAPAGLIFLOZIN, GLICLAZIDE AND METFORMIN IN PHARMACEUTICAL DOSAGE FORM BY RP-HPLC

Abstract

The present study focuses on the development and validation of a simple, accurate, precise, and robust reverse-phase high-performance liquid chromatography (RP-HPLC) method for the simultaneous estimation of Dapagliflozin, Gliclazide, and Metformin in pharmaceutical dosage forms. These drugs are widely used in the management of type 2 diabetes mellitus and are available in various combination formulations. The proposed analytical method was developed by optimizing chromatographic conditions, including stationary phase, mobile phase composition, flow rate, detection wavelength, injection volume, and run time, to achieve satisfactory separation of the selected drugs. Chromatographic separation was achieved using a suitable reversed-phase C18 column with an optimized mobile phase under isocratic conditions. The developed method was validated according to International Council for Harmonization (ICH) guidelines with respect to specificity, linearity, accuracy, precision, robustness, limit of detection, and limit of quantification. The method demonstrated good linearity over the selected concentration ranges, with satisfactory recovery and precision. No significant interference was observed from excipients present in the pharmaceutical dosage form. The developed method was found to be rapid, economical, reproducible, and suitable for routine quality control analysis of Dapagliflozin, Gliclazide, and Metformin in combined pharmaceutical formulations. The method may also provide a reliable analytical approach for quality assessment during formulation development and stability studies.