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.
Development And Validation Of Analytical Method For The Estimation Of Related Impurities In Combined Dosage Form Of Aspirin And Prasugrel Hydrochloride By Rp-Hplc
Research Article
DOI:
http://dx.doi.org/10.24327/ijrsr.2019.1006.3573
Subject:
science
KeyWords:
Aspirin, Prasugrel Hydrochloride, Impurities, RP-HPLC, Method Development, Validation.
Abstract: