Method Development, Validation and Forced Degradation Studies of Dapagliflozin and Pioglitazone Hydrochlorides in Synthetic Mixtures by RP-HPLC
Major/Area of Research
Pharmaceutical Sciences
Description
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.
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.