DEVELOPMENT OF A NEW STABILITY INDICATING RP-HPLC METHOD FOR SIMULTANEOUS ESTIMATION OF SAXAGLIPTINE AND DAPAGLIFLOZIN AND ITS VALIDATION AS PER ICH GUIDELINES

A new stability indicating RP HPLC method has been developed and validated for simultaneous estimation of Saxagliptine and Dapagliflozin in bulk and dosage forms. The method involves separation on XTerra C 18 column (150mm x 4.6mm x5µm particle size). The optimized mobile phase consists of phoaphate buffer (pH 4) and Acetonitrile (50:50v/v) with a flow rate of 1ml/min and UV detection at 225mn. Retention time was 2.1min (Saxagliptine), 2.8min (Dapagliflozin). Linearity range was 20-60ug/ml (Saxagliptine), 40-120ug/ml (Dapagliflozin). Accuracy was in the range of 99.99-100.50% for both drugs. Precision was 0.78% and 0.44% for Saxagliptine and Dapagliflozin. LOD and LOQ are 1.63ug/ml and 5.39ug/ml for Saxagliptine, 1.94ug/ml and 6.50ug/ml for Dapagliflozin. The method developed is more sensitive, accurate and precise than the methods reported earlier. Retention time and run time were also less and hence the method is economical. When applied for tablet assay, drug content was within 100.24-100.43 % of labeled content. Forced degradation studies indicated the suitability of the method for stability studies. Key Words: Saxagliptine, Dapagliflozin, RP-HPLC Method, Simultaneous estimation, Validation as per ICH guidelines, Forced degradation studies.