Application of Quality by Design Approach for Development and Validation of Analytical RP-HPLC Method for Prasugrel HCL in Bulk and Tablet Dosage Form

QbD is a systematic risk based, proactive approach to pharmaceutical development that begins with predefined objectives and emphasizes product and process understanding. The present study describes Application of Quality by Design approach to the development and validation of analytical RP-HPLC method for Prasugrel HCl. Optimization was done by response surface methodology, applying a three level Box-Behnken design. Three factors selected were flow rate, pH, and concentration of methanol and water in mobile phase. The optimized chromatographic method was validated according to the International Conference on Harmonization (ICH) Q2 (R1) guidelines for linearity, precision, range, accuracy and robustness. Detection was done using UV detector at 254 nm. The developed method employed mobile phase methanol: water (pH 3.5) (94.7: 5.3), and flow rate 1.1 ml/min, which was optimized with the help of design expert software. High linearity of the developed method was confirmed over concentration range of 100-400 g/ml for Prasugrel HCl with correlation coefficient of 0.999. The percentage RSD for precision and accuracy of the method was found to be less than 2 %. The proposed method can be successfully used to determine the drug contents of marketed formulation.