Analytical Quality by Design Approach To RP-HPLC Method Development and Validation of Dapagliflozin and Vildagliptin

<p><span>This study presents a novel approach for the concurrent quantification of Dapagliflozin and Vildagliptin in tablet form. Chromatogram was analysed using a Discovery C18 column (4.6 x 150mm, 5µm). A mobile phase consisting of Acetonitrile and Na2hpo4 prepared in a 70:30 ratio was passed down the column at a flow rate of 0.8 ml/min. The solution employed in this technique is a phosphate buffer, and the pH is modified to 5.2 by the addition of 0.1% Formic acid. The temperature was kept constant at 30°C. The selected optimised wavelength was 220 nm. The observed retention times for Dapagliflozin and Vildagliptin were 2.307 minutes and 2.865 minutes, respectively. The relative standard deviation (RSD) of Dapagliflozin and Vildagliptin were determined to be 0.9 and 0.7 correspondingly. The observed recovery rates for Dapagliflozin and Vildagliptin were 100.41% and 99.94% respectively. The limit of detection (LOD) and limit of quantification (LOQ) values derived from the regression equations of Dapagliflozin and Vildagliptin were 0.02, 0.07, and 0.24, 0.72 correspondingly. The regression equation for Dapagliflozin is provided as y = 42540x + 1488.4. Furthermore, the equation y = 38485x + 2186.5 of Vildagliptin. By reducing retention times and run time, the new approach proved to be easy and cost-effective for use in routine quality control tests in industries.</span></p>