POTENTIAL OF RP-HPLC-DAD-MS FOR THE QUALITATIVE AND QUANTITATIVE ANALYSIS OF DAPAGLIFLOZIN IN TABLETS AND DEGRADANTS

摘要

Dapagliflozin is a new drug of the gliflozin class which inhibits subtype 2 of the sodium-glucose transport proteins (SGLT2). It is a recent drug in the market and the generic market may soon get flooded with it. Therefore, newer methods are required to control dapagliflozin in pharmaceuticals. In the present study, a new method based on RPHPLC coupled to DAD and MS was developed to validate the analysis of dapagliflozin in tablet dosage form. A wavelength of 222 nm was selected to perform a cost-effective quantification and the method showed adequate linearity, with an R2 value of 0.9998, and acceptable values of accuracy (75%-102%) and precision (residual standard deviation < 5%). The detection and quantification limits were 1.16 ug/mL and 0.53 ug/mL, respectively. Furthermore, the use of high-resolution MS enabled us to ensure the specificity, check impurities and better sensitivity. Therefore, this methodology promises to be suitable not only for the routine analysis of dapagliflozin in pharmaceutical dosage forms, but also for potential degradants.