POTENTIAL OF RP-HPLC-DAD-MS FOR THE QUALITATIVE AND QUANTITATIVE ANALYSIS OF DAPAGLIFLOZIN IN TABLETS AND DEGRADANTS
Journal: Indian Drugs (Vol.55, No. 11)Publication Date: 2018-11-28
Authors : Agarwal B.; Gandhi S.;
Page : 45-49
Keywords : ;
- DEVELOPMENT AND VALIDATION OF A UV SPECTROPHOTOMETRIC Q-ABSORBANCE RATIO METHOD FOR SIMULTANEOUS ESTIMATION OF EPERISONE HYDROCHLORIDE AND ACECLOFENAC IN BULK AND TABLET DOSAGE FORM
- ESTIMATION OF MONTELUKAST SODIUM AND FEXOFENADINE HYDROCHLORIDE IN BULK AND TABLET DOSAGE FORM BY Q-ABSORBANCE METHOD
- DEVELOPMENT AND VALIDATION OF NOVEL STABILITY INDICATING UV SPECTROPHOTOMETRIC METHOD FOR THE ESTIMATION OF CINACALCET HYDROCHLORIDE IN BULK AND TABLET DOSAGE FORMS
- Development and Validation of First Order Derivative Spectrophotometric Method for Simultaneous Estimation of Bromhexine Hydrochloride and Phenylephrine Hydrochloride in their Combined Pharmaceutical Dosage Form
- Development and Validation of UV Spectrophotometric Method for Simultaneous Estimation of Metformin and Glipizide in Tablet Dosage Form
Abstract
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 μg/mL and 0.53 μg/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.
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Last modified: 2018-11-30 13:07:39