Considering todays regulatory requirement for the development of an analytical method, a reversed phase high performance liquid chromatography method for simultaneous estimation of aspirin and prasugrel HCl in capsule dosage form has been optimized by analytical quality by design approach. Unlike the regular approach, this study began with the understanding of the objective profile of the quality product, the objective analytical profile and the risk assessment for the method variables that affect the response of the method. A liquid chromatography system equipped with a waters C18 column (150×3.9 mm, 5 μm), a isocratic delivery system (pump) and photodiode array detector were used to develop the method. The optimized method was achieved at 0.7 ml/min flow rate of using mobile phase of 1% Phosphoric acid buffer and Acetonitrile at 20:80( v/v), pH was adjusted to 3.5 with tri ethylene amine. To plan and analyses the experimental observations and obtain quadratic process model Design Expert software Version 11 was used. The process model was used for predicting solution for resolution. The optimized working condition was then validated according to ICH guidelines for linearity, LOD, LOQ, specificity.

Keywords : Quality by Design, Plackett-Burman, Box Behnken, HPLC, Aspirin, Prasugrel HCl.