RP-HPLC Based Analytical Method Development and Validation of Sotagliflozin in Pharmaceutical Dosage Form

A rapid and precise method (in accordance with ICH guidelines) is required for the quantitative simultaneous determination of singal drugs in a pharmaceutical dosage form. The pursuit of desired quality is a continual challenge for pharmaceutical industries, necessitating a meticulous approach known as validation. Sensitive and specific RP-HPLC method involving UV detection was carried for determination and quantification of various drug in singal dosage form. The aim is "Analytical Method developement and Validation of Sotagliflozin. Sotagliflozin by RP- HPLC In Singal  Dosage Form " as per ICH guidelines. The developed method was validated for various parameters as per ICH guidelines like system suitability, specificity, linearity, system precision, method precision, accuracy, ruggedness and robustness. The separation method was carried out by using a mobile phase A consisting of Potassium dihydrogen phosphate buffer (0.05M): Methanol 45:55 v/v) pH 3.5 ± 0.1 and Mobile phase B comprises Acetonitrile in the ratio of 50:50 v/v. The detection was carried out by using UV detector at 300nm. The column was Agilent C 18 (250X4.6mm) 5µ. The flow rate was selected as 1.5 ml/min. The retention time of Of  Sotagliflozin  was found to be  3.29 min.