DEVELOPMENT AND VALIDATION OF RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF DAPAGLIFLOZIN AND METFORMIN IN BULK AND IN MARKETED FORMULATION

*Yasika S., Dr. P. Aravanan

ABSTRACT

The simultaneous determination of Metformin and Dapagliflozin in synthetic mixtures was successfully achieved through the development of a validated, precise, and simple reverse-phase HPLC method. The therapeutic combination of Dapagliflozin and Metformin Hydrochloride hasbecome a cornerstone in the management of Type 2 Diabetes Mellitus, as it simultaneously enhances insulin sensitivity and facilitates glucose clearance via renal pathways. Because of this pharmacological synergy, establishing rigorous and dependable analytical frameworks is vital for the concurrent measurement of these drugs in both clinical samples and manufactured tablets. This assessment explores a variety of established analytical techniques used to quantify Dapagliflozin and Metformin, whether they are analyzed individually or as a fixed-dose combination. In the landscape of pharmaceutical analysis, Reversed-Phase High-Performance Liquid Chromatography (RP-HPLC) is the most widely adopted methodology for this specific drug pair. Its popularity stems from its ability to provide high resolution and reproducible results for molecules with divergent chemical properties. This review offers a detailed summary of the analytical techniques that are currently available and highlights the significance of method validation in achieving accurate and consistent results for the simultaneous measurement of dapagliflozin and metformin hydrochloride.

Keywords: Dapagliflozin, Metformin hydrochloride, RP-HPLC, Diabetes mellitus.