Rp-Hplc Method Development and Validation of Sotagliflozin

Abstract

The present study aimed to develop and validate a reverse-phase high-performance liquid chromatography (RP-HPLC) method for the quantitative estimation of sotagliflozin. A Quality by Design (QbD)-based approach using response surface methodology and a three-factor, three-level Box–Behnken design was employed to optimize the chromatographic conditions. Chromatographic separation was performed using a C18 column with a mobile phase consisting of methanol and water in a ratio of 80:20 (v/v). The flow rate was maintained at 1.0 mL/min, with UV detection at 232 nm and an injection volume of 20 µL. The total run time was 10 minutes. The developed method was evaluated for linearity, precision, robustness, limit of detection (LOD), and limit of quantification (LOQ). Linearity was established over a concentration range of 2–12 ppm, with a coefficient of determination (R²) of 0.997. System precision and method precision demonstrated %RSD values of 0.406% and 0.147%, respectively. Intraday and interday precision studies showed %RSD values below 1%, indicating good reproducibility. Robustness studies demonstrated acceptable performance following minor variations in wavelength and injection volume. The LOD and LOQ were determined to be 0.61 ppm and 1.86 ppm, respectively. Overall, the developed RP-HPLC method demonstrated satisfactory linearity, precision, sensitivity, and robustness, indicating its potential suitability for the routine quantitative analysis of sotagliflozin in pharmaceutical quality-control laboratories.