Analytical Methods for Simultaneous Estimation of SGLT2 Inhibitor and DPP-4 Inhibitor in their Combination for Treatment of Type 2 Diabetes Mellitus

Abstract

The Saxagliptin Hydrochloride (SAXA) and Dapagliflozin (DAPA) Fixed-Dose Combination has recently been approved for the treatment of Mellitus type 2 diabetes. In order to simultaneously estimate SAXA and DAPA is a bulk product and its formulation, the study aimed at developing a simple, fast, sensitive, and validated UV-Spectrophotometric and reversed-phase high-performance liquid chromatography (RP-HPLC) methods. Simultaneous equation UV method was performed on Shimadzu UV-1800 Spectrophotometer based on measurement of SAXA and DAPA absorption in methanol at 210 nm and 224 nm, respectively, over 6-22 μg / mL and 12-44 μg / mL linear ranges. RP-HPLC method was designed using an HPLC system-equipped PDA detector. The method has been validated for SAXA and DAPA for a range of 8 to 22 μg / ml and from 16 to 44 μg / mL. In compliance with ICH guideline Q2(R1), the optimal approach is successfully validated. The results showed that the method was accurate (98.22–100.28 percent w / w and 99.48–100.15 percent w / w SAXA and DAPA, respectively) and precise (percentage of relative standard deviation < 2.0). Developed methods follow ICH Q2 (R1) criteria and sufficient to apply regulatory versatility for submission.