Development and Validation of a New HPLC Method for the Simultaneous Estimation of Saxagliptine and Dapagliflozin and Its Application in Pharmacokinetic Studies

A New HPLC method for the simultaneous estimation of Saxagliptine and Dapagliflozin in their combine dosage form was developed and validated as per the ICH guidelines. The method involves separation on XTerra C18 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 225nm. Retention time was 2.1min (Saxagliptine), 2.8min (Dapagliflozin). Linearity was observed in the range of 20-60µg/ml for Saxagliptine and 10-120µg/ml for Dapagliflozin with correlation coefficients (r2=0.999). The percentage recoveries of Saxagliptine and Dapagliflozin were in the range of 99.99-100.50% which was with in the acceptance criteria. The percent RSD was NMT 2% which proved the precision of the developed method. The developed method is simple, specific, sensitive, precise and accurate and was found suitable for estimation of Saxagliptine and Dapagliflozin in bulk and dosage forms. The developed HPLC method was also found suitable for application in pharmacokinetic studies for the estimation of Saxagliptine and Dapagliflozin in plasma samples.In the real in vivo pharmacokinetic study the biological half-lives (t1/2) of Saxagliptine and Dapagliflozin estimated by the proposed method are in good agreement with the literature values. The good agreement of the absorption and elimination parameters estimated using HPLC method developed with those of literature values indicated that newly developed HPLC method is suitable and could be used in pharmacokinetic studies.