SIMPLE HIGH PERFORMANCE LIQUID CHROMATOGRAPHY METHOD FOR SIMULTANEOUS QUANTIFICATION OF SAXAGLIPTIN AND DAPAGLIFLOZIN IN RAT PLASMA

Abstract

A simple HPLC method was developed for the simultaneous estimation of saxagliptin and dapagliflozin in rat plasma. The separation has been achieved by C8 Eclipse plus column (25cm x 5cm x 4.6µ) at 1 mL min-1 flow rate. The mobile phase comprises of 0.01 % trimethylamine in water and methanol (40:60 V/V). The effluents were monitored at 228 nm. The retention times were found to be 4.243 min and 11.304 min for saxagliptin and dapagliflozin, respectively. The quantification ranges were found to be linear over 25-175 ng mL-1 and 100-700 ng mL-1 for saxagliptin and dapagliflozin, respectively. Regression equations of saxagliptin and dapagliflozin were found to be y = 594.84x - 801.14 and y = 128.6x - 348.57 with regression coefficient (R2 ) 0.9988 and 0.9963, respectively using weighting factor of 1/x0 , 1/x, 1/√x, and 1/x2 . The percentage recoveries were 81.51±1.276 to 86.23±2.012 and 81.48±2.487 to 85.40±2.145 for saxagliptin and dapagliflozin, respectively. This reported method was extensively validated according to US-FDA guideline.