Abstract

SIMULTANEOUS METHOD DEVELOPMENT AND VALIDATION FOR ESTIMATION OF SODIUM-GLUCOSE COTRANSPORTER 2 (SGLT2) INHIBITOR AND DIPEPTIDYL PEPTIDASE-4 (DPP-4) INHIBITOR BY RP-HPLC

V. Mounika*, R. Jayanthi and G. Indira Priyadarshini

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Abstract

A rapid and precise RP-HPLC method was developed and validated for the simultaneous estimation of Dapagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, and Saxagliptin, a dipeptidyl peptidase-4 (DPP-4) inhibitor, in pharmaceutical formulations. The method employed a Shimadzu LC-20AD system with a photodiode array detector and an Agilent C18 column. The mobile phase consisted of methanol and sodium acetate buffer at a 55:45 ratio, with a flow rate of 1.0 ml/min, and the detection wavelength was set at 228 nm. The retention times for Dapagliflozin and Saxagliptin were 2.314 minutes and 2.904 minutes, respectively. Method validation followed ICH guidelines, demonstrating high precision with % RSD values below 2% for both drugs. The linearity of the method was confirmed with R² values close to 0.999 for both analytes. The LOD and LOQ were 0.439 μg/ml and 1.33 μg/ml for Dapagliflozin and 0.257 μg/ml and 0.780 μg/ml for Saxagliptin, respectively. Forced degradation studies revealed the stability of both drugs under various stress conditions, with minor degradation observed. The method was successfully applied to the analysis of the marketed formulation Qtern, achieving accurate quantification with a % assay close to the labeled claim. This method offers a reliable and efficient approach to the routine analysis of these antidiabetic agents.

Keywords: RP-HPLC, Dapagliflozin, Saxagliptin, Simultaneous Estimation, Method Validation, Forced Degradation, Qtern.