METHOD DEVELOPMENT AND VALIDATION OF DAPAGLIFLOZIN AND SAXAGLIPTIN BY RP-HPLC

Abstract

For the coincident evaluation of Dapagliflozin and Saxagliptin in bulk form; Chromatography was run through Intersil-ODS C18 column (250mm× 4.6mm, 5micron) Mobile phase containing Methanol: Water was pumped through the column in the ratio of 45: 55. The flow rate was 1ml/min. The temperature help was ambient i.e., upto300c. The optimized selected wavelength was 210nm. The retention time of Dapagliflozin and Saxagliptin was found to be 4.707min and6.68 min respectively. The %RSD of Dapagliflozin and Saxagliptin was found to be 0.031 and 0.036 respectively. The values of LOD and LOQ obtained from Dapagliflozin and Saxagliptin was 0.56, 1.69 and 0.57, 1.74 respectively. The retention time was decreased and the run time also decreased, so the method development was simple and economical that can be applied successfully for simultaneous estimation of combination of two anti- diabetic drugs; Dapagliflozin and Saxagliptin. KEY WORDS: Dapagliflozin and Saxagliptin, RP-HPLC.