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 discovered 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. Mr. Tarang Patel | Ronak Parikh "Method Development, Validation and Forced Degradation Studies of Dapagliflozin and Pioglitazone Hydrochlorides in Synthetic Mixtures by RP-HPLC" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-6 , October 2022, URL: https://www.ijtsrd.com/papers/ijtsrd52165.pdf Paper URL: https://www.ijtsrd.com/pharmacy/analytical-chemistry/52165/method-development-validation-and-forced-degradation-studies-of-dapagliflozin-and-pioglitazone-hydrochlorides-in-synthetic-mixtures-by-rphplc/mr-tarang-patel