M. Kavitha*, C.S. Parameswari, B.V. Ramana, G. Nagarajan
Dr.K.V.Subba Reddy Institute of Pharmacy, Kurnool, Andhra Pradesh, India
A B S T R A C T
The aim of present research work made to develop and validate RP-HPLC method for the simultaneous estimation of Dapagliflozin and Saxagliptin in bulk and combined dosage form. The optimized mobile phase was consists of 0.1% OPA: Methanol: Acetonitrile (30: 60: 10) and chromatographic separation was carried on Xterra C 18, column (4.6*150mm, 5µ). The detection of absorption maxima was monitored at 225nm. The flow rate was maintained at 1.0 ml/min. The linear concentration Dapagliflozin and Saxagliptin were found to be from 20-100 µg/ml and 10-50 µg/ml with regression coefficient was 0.999 for both drugs. The values of % RSD are less than 2% indicating accuracy and precision of the method. The mean percentage recovery was found to be 100.64% of Dapagliflozin and 100.36% of Saxagliptin. The proposed method is precise, simple and accurate to determine the amount of Dapagliflozin and Saxagliptinin formulation. So the method can be useful in the routine quality control of these drugs.
Keywords: Dapagliflozin and Saxagliptin, RP-HPLC, Mobile phase, Accuracy, Regression coefficient