A simple, economic, selective and precise RP-HPLC method has been developed and validated for the estimation of related impurities of Aspirin and Prasugrel Hydrochloride in combined dosage form. A gradient reverse phase high performance liquid chromatography (RP-HPLC) analysis was performed on Hypersil BDS C18 column (250mm X 4.6mm, 5µm) using mobile phase A: 0.05M Ammonium acetate buffer pH-3.0 and mobile phase B:Acetonitrile at a flow rate of 1.0 ml/min and the detection wavelength was 224nm. The analytical method was validated according to ICH guidelines. The linearity was observed in the range of 4-22.5µg/ml for related impurities of Aspirin and 0.5-3µg/ml for related impurities of Prasugrel Hydrochloride with correlation coefficient more than 0.990 for related impurities of Aspirin and Prasugrel Hydrochloride. The % recovery value was found minimum of 95.62% and maximum of 104.50% for all known impurities of Aspirin and Prasugrel Hydrochloride. The relative standard deviation value for repeatability, interday precision and intraday precision was less than 5%. The LOD value was found minimum of 0.09µg/ml and maximum of 1.49µg/mlfor all known impurities. The LOQ value was found minimum of 0.28µg/ml and maximum of 4.52µg/mlfor all known impurities.The proposed method was found to be specific, linear, sensitive, precise, accurate and robust in nature.
