Applying kinetics principles to drug degradation studies helps in determine the expiration dates of drugs and formulations. An accurate, precise and sensitive stability-indicating high-performance liquid chromatographic method was developed and validated to study the degradation kinetics of Dapagliflozin (DGZ). DGZ was degraded under different stress conditions and degraded samples were chromatographed on C 18 (150 mm × 4.6 mm, 5 µm) column, separated using solvent system acetonitrile and 0.01% triethylamine solution (pH 5 adjusted with orthophosphoric acid) in a ratio of 70:30 v/v and detected at 270 nm. The design of experiments (DOEs) was applied to study the degradation kinetics of DGZ in the oxidative medium. The effect of temperature and concentration of H 2 O 2 on the order of reaction and % degradation was studied at three levels using a full factorial design. The linearity range for DGZ was 1-60 µg/mL (correlation coefficient = 0.9996) with an average recovery of 99.98%. The limit of detection (LOD) and limit of quantitation (LOQ) for DGZ were 0.07 and 0.22 µg/mL, respectively. Degradation of DGZ in the oxidative medium was found to follow first-order kinetics. Contour plots have been generated to predict the degradation rate constant and % degradation of DGZ in different combinations of temperature and concentration of H 2 O 2 using Design Expert software (Trial version).
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