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.
Novel approach for the determination of azithromycin in pharmaceutical formulations by Fourier transform infrared spectroscopy in film-through transmission mode
