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SIMULTANEOUS SPECTROPHOTOMETRIC DETERMINATION OF DAPAGLIFLOZIN AND SAXAGLIPTIN IN FIXED DOSE COMBINATION (FDC) BY Q-ABSORBANCE RATIO METHOD

Gan Ee Howa and Bontha Venkata Subrahmanya Lokesh*a

a Faculty of Pharmaceutical Sciences, UCSI University, Kuala Lumpur, Malaysia.

* For Correspondence: E-mail: dungeon431@hotmail.com / lokeshb@ucsiuniversity.edu.my


ABSTRACT

A simple Q-absorbance ratio method have been developed for the determination of dapagliflozin (DAPA) and saxagliptin (SAXA) in fixed dose combination (FDC) using UV-Visible spectrophotometer. In this method, the UV spectra of DAPA and SAXA were overlaid to obtain wavelength at isosbestic point (λiso) of 217.6 nm and at absorption maximum (λmax) of DAPA at 224.2 nm, which are involved in the formation of Q-absorbance equation. Validation of method was done according to ICH guidelines. DAPA and SAXA obeyed Beers law in the concentration range of 2-25 µg/mL and 5-25 µg/mL, respectively. Good accuracy of method was determined by recovery studies and found to be in the range of 103.1-104.6% for DAPA and 97.7-102.4% for SAXA. This method has shown good precision (%RSD < 2.0). Statistical analysis like one-way ANOVA and student t-test were conducted and the reported method was accurate. This method was found to be simple, cheap, eco-friendly accurate and precise and can be used for routine analysis of DAPA and SAXA in FDC for testing regularly in manufacturing units.

Year 2020 | Volume No. 57 | Issue No.11 | Page No. 63-75
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