DEVELOPMENT AND VALIDATION OF A UV SPECTROSCOPIC METHOD FOR DETERMINATION OF SOTAGLIFLOZIN

Background and Objective: Sotagliflozin is recommended for patients to reduce the risk of heart failure, type 2 diabetes and chronic kidney diseases. Since there were no analytical methods reported for the estimation of Sotagliflozin till date, the present work aims to develop and validate a UV spectrophotometric method for the evaluation of Sotagliflozin in bulk. Method: By using Lab India UV spectrophotometer, the standard solution was scanned against blank in the range of 200-400 nm and the λ max was determined using UV Analyst software. Validation of the method was performed as per ICH guidelines. Results: The λ max of the drug Sotagliflozin was obtained at 285 nm. The developed UV spectrophotometric method for the determination of Sotagliflozin was validated and results obtained were within the acceptance criteria. Hence the method was found to be precise, accurate, linear, robust and rugged with % Relative standard deviation (RSD) not more than 2, and the linearity solutions were scanned in the concentration range of 100 to 500 µg/mL and by calculating the correlation coefficient (R2 value) for the above concentration range the value obtained was 0.996. Conclusion: UV Spectrophotometric method was developed for the determination of Sotagliflozin and the method was validated according to ICH guidelines requirements. This method can be recommended for routine analysis and quality control.