Journal of Chemical and Pharmaceutical Research (ISSN : 0975-7384)

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Original Articles: 2010 Vol: 2 Issue: 4

Development and validation of stability indicating HPTLC method for determination of Prasugrel

Abstract

A sensitive, selective, precise and stability indicating (in accordance with ICH guidelines) High- Performance Thin Layer Chromatographic method of analysis for Prasugrel was developed, to resolve drug response from that of their degradation products. The method employed TLC aluminium plates precoated with silica gel 60 F254 as the stationary phase. The solvent system consisted of Dichloromethane: Methanol (9.9:0.1v/v). This system was found to give compact spot for Prasugrel (Rf value 0.58±0.03). Prasugrel was subjected to stress test conditions like acid, alkali, neutral hydrolysis, oxidation, dry heat and photo degradation. The spot for product of degradation was well resolved from the drug. Densitometric analysis of drug was carried out in the absorbance mode at 254 nm. The linear regression data for the calibration plots showed good linear relationship with r2 was 0.995 in the concentration range of 300-1500ng/band. The result indicates that the drug was susceptible to degradation, to different extent in different conditions.