Author:
Sabbagh B.,Lokesh B. V. S,Akowuah G. A.,
Abstract
Dapagliflozin (DAPA) is a promising novel antidiabetic agent, approved by the Food and Drug Administration in 2014. There is a lack of analytical methods for routine quality control of DAPA in pharmaceutical formulations. A validated Attenuated Total Reflectance Fourier Transform Infrared Spectroscopy (ATR-FTIR) method is presented for the determination of DAPA in tablets. The calibration curve is constructed on peak height location at a specific wavenumber of 1065 cm-1 with correlation coefficient of 0.997. The limit of detection (LOD) and limit of quantification (LOQ) were 0.008(%w/w) and 0.04 (%w/w), respectively. The method was found to be precise over a range of 10- 100%, with intra-day and inter-day precision values less than 8 and 11, respectively. The percentage of mean recovery was estimated at 96.15 ±3.45. The validated method was used for the quantification of DAPA in tablets and percentage of labeled amount was found to be 96.15 ±3.45. No significant interference was observed by excipients in the tablet formulation during the spectral analysis.
Publisher
Indian Drug Manufacturers' Association (IDMA)
Subject
Drug Discovery,Pharmaceutical Science,Pharmacology
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