QBD Driven Analytical Method Development and Validation for Sotagliflozin in bulk and Pharmaceutical Dosage Form by RP- HPLC

Abstract

A simple, sensitive, and precise reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed and validated for the quantitative estimation of Sotagliflozin in bulk and pharmaceutical dosage forms, following ICH Q2(R1) guidelines. Chromatographic separation was achieved using an Inspire C18 column (3.0 × 150 mm, 5 µm) with a mobile phase comprising phosphate buffer (pH 5.8) and methanol in a 70:30 v/v ratio at a flow rate of 1.0 mL/min. Detection was performed at 221 nm using a PDA detector, with an injection volume of 10 μL and a run time of 20 minutes. The method demonstrated excellent linearity in the range of 10–50 μg/mL, with a correlation coefficient (R²) of 0.9996. System suitability parameters, including a USP plate count of 7801.77 and a tailing factor of 1.02, complied with acceptance criteria. Precision studies showed %RSD values of 0.11% (repeatability) and 0.12% (intermediate precision), indicating high reproducibility. Accuracy results yielded a mean recovery of 100.3%, confirming method reliability. The limits of detection (LOD) and quantification (LOQ) were found to be 0.03 μg/mL and 0.09 μg/mL, respectively. Robustness testing demonstrated that deliberate variations in flow rate and mobile phase composition did not significantly affect chromatographic performance. This validated RP-HPLC method is reliable, rapid, and cost-effective, making it suitable for routine quality control and regulatory compliance testing of Sotagliflozin in pharmaceutical formulations.