A Study of New Method Development, Validation and Forced Degradation for Simultaneous Analysis of Dapagliflozin and Saxagliptin in Pharmaceutical Dosage Form by HPLC Method
Phani RSCH, Prasad KRS, Useni Reddy Mallu
A simple, precise and stability-indicating Reversed Phase High Performance Liquid Chromatography (RP-HPLC) method has been developed for simultaneous quantification of Dapagliflozin (DGFZ) and Saxagliptin (SGPT) in combined dosage form. The developed method has been validated with respect to precision, linearity, accuracy, robustness, ruggedness, sensitivity, solution stability. The method has been developed with ammonium dihydrogen phosphate buffer (pH 6.8) and methanol in a ratio of 65:35 v/v as mobile phase at a flow rate of 1.5 ml/min over Intersil ODS C18 column (250 mm × 4.6 mm × 5 μ). The UV detection wavelength was fixed at 280 nm. The column temperature being maintained at ambient temperature. The method shown good linearity with correlation coefficient values of 0.9992 and 0.999 for DGFZ and SGPT. The percent recoveries of two drugs found within the limits of (98.00-102.0%). The Limit of Quantification (LOQ) concentrations of DGFZ and SGPT are 0.312 μg/ml and 0.156 μg/ml respectively. The Limit of Detection (LOD) concentrations of DGFZ and SGPT are 0.156 μg/ml and 0.078 μg/ml respectively. According to International Conference on Harmonization (ICH) guidelines Forced degradation study was validated.