Development and validation of stability indicating UPLC method for the estimation of Sotagliflozin and characterization of its degradation products by UPLC-MS/MS

A simple, specific, validated reverse phase UPLC method has been developed for the estimation of Sotagliflozin and its degradation products, identified by UPLC-MS. As per our knowledge, no chromatographic method has been reported in the literature so far for the estimation of Sotagliflozin and its degradants. This method employs a chromatographic separation using a Phenyl Column (100 × 1.0 mm, 1.7 µm). The phase of mobility comprised of 0.1% FA: ACN in 50:50 v/v ratio with a flow rate of 0.2 mL/min at room temperature. The UV measurement was taken at 242 nm using a PDA detector and Empower-2.0 software. The retention time of Sotagliflozin was found to be 0.761 min. It was determined that the results, consistency and measurement limitations had been acceptable and in the admissible range. The established method was validated statistically in terms of specificity, linearity, LOD, LOQ, precision, accuracy and robustness according to ICH guidelines, found to be within the specified limits. The narrated method showed excellent linearity within the concentration range of 4–60 µg/mL (R² = 0.9998) with regression equation y = 64712.07<i>x</i> + 46933.12. The LOD and LOQ values of Sotagliflozin were found to be 0.12 µg/mL (<i>s</i>/<i>n</i> = 3) and 0.4 µg/mL (<i>s</i>/<i>n</i> = 10) respectively. The mean percentage recoveries were ranging from 100.3–100.6% for Sotagliflozin. The RSD values of all the analytical method validation parameters were found to be less than 2%. The forced degradation studies were conducted as per ICHQ2(R) guidelines and UPLC-MS had been utilized for the confirmation of structures of Sotagliflozin breakdown substances. The peaks of the degradants were well resolved from those of pure drug with significant differences in their retention times with acceptable tailing and resolution. The proposed method can be applicable for the estimation of Sotagliflozin in the presence of its degradation products. In order to avoid potential instability, these experiments furnish the information about the conditions under which Sotagliflozin was unstable and appropriate precautions were made during the process of formulation. This method plays a significant role in various pharmaceutical applications, including quality control, stability testing, shelf-life determination and packaging integrity-optimization.