Two methods were developed for the determination of dapagliflozin (DAPA) in pure form and in tablets. The procedure utilized was UV-Visible Spectroscopy and RP-HPLC with PDA detector to quantify DAPA in bulk and tablets. The sensitive linear range was identified for both methods within 0.5-5.0μg/mL. The linear regression analysis was identified for both methods with correlation coefficient(r)>0.99. The LOD and LOQ values were found to be 0.05 μg/mL and 0.5 μg/mL for the method by UV-Spectroscopy. The molar absorptivity (ε) was calculated as 1.27 X 105 L.mol-1cm-1. The RP-HPLC method produced LOD and LOQ values of 1.0 ng/mL and 0.5 μg/mL. Both methods were simple, precise, reproducible to quantify the amount of unknown in bulk as well as in tablets and estimated accurately within the range of 100.0±0.5%. Statistical analysis was performed on the data obtained. There was no significant difference between the developed and reported methods with p>0.05. Both methods can be applied for routine analysis of DAPA in bulk and tablets with good accuracy and precision.

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.