Method Development, Validation and Forced Degradation Studies of Dapagliflozin and Pioglitazone Hydrochlorides in Synthetic Mixtures by RP-HPLC

A simple, sensitive, robust, precise, and efficient RP-HPLC approach for the simultaneous determination of Dapagliflozin and Pioglitazone Hydrochloride in Synthetic Mixture. As per ICH Q2 (R1) guidelines, the final chromatographic conditions were Optimized with a mobile phase ratio of (25:75% v/v) in ACN: Potassium Dihydrogen Phosphate Buffer (pH 4) was adjusted by adding OPA at a flow rate of 1 mL/min, column temperature of 30 °C, injection volume of 20 μL, Kromstar Vertex C18 analytical column, and UV detection at 228 nm wavelength. Dapagliflozin and Pioglitazone Hydrochloride reported retention times of 3 min and 6.5 min, respectively. Validation of a method was found to be linear in the range of 2-10 μg/ml for Dapagliflozin and 3–15 μg/mL for Pioglitazone Hydrochloride. The % Recovery for Dapagliflozin was dis- covered to be 98.52 - 99.90 %, while for Pioglitazone Hydrochloride, it was found to be 99.67- 99.94 %. The Precision results for both drugs were within the limits while expressed Intraday and Interday. For Dapagliflozin, the LOD and LOQ were reported to be 0.041 μg/mL and 0.13 μg/mL, respectively, and for Pioglitazone Hydrochloride, 0.105 μg/ mL and 0.32 μg/mL. As per ICH Q1A (R2) guidelines, the synthetic mixture was subjected to acid, base, oxidation, thermal, and photolysis stress conditions.