Abstract

DEVELOPMENT AND VALIDATION OF STABILITY INDICATING RP-HPLC METHOD FOR PRASUGREL HYDROCHLORIDE

T. Naga Jhansi*, D. Jaya Deep Kumar, G. Nageswara Rao, R. Naga Raju

ABSTRACT

This work describes development and validation of Reverse phase -HPLC method for the separation of Prasugrel hydrochloride and its related in-house impurities. This method is capable to separate the in-house impurities along with the specificity of all pharmacopoeial impurities on X-Bridge C18, 150 mm x4.6mm, 3.5μm column with 35 min run time. Buffer was selected as 25 mM KH2PO4 with pH 4.0. Mixture of buffer and acetonitrile in the ratio 80:20 v/v selected as mobile phase –A and acetonitrile and water in the ratio 80:20 v/v selected as mobile phase-B. The flow rate was 1.0 mL/min and column temperature was 45° C. The wavelength was selected at 210 nm and diluent selected as acetonitrile and water in the ratio 70:30 v/v. Injection volume was 5.0 μL. The drug substance was subjected to stress studies such as hydrolysis, oxidation & thermal degradation, and considerable degradation was observed in acidic hydrolysis and thermal stress conditions. The formed degradation products were well-resolved from the Prasugrel hydrochloride and its related substances. The validated method produced good results of precision, linearity, accuracy, robustness and ruggedness. The proposed method was found to be suitable for the quantitative determination of related impurities in the API samples of Prasugrel hydrochloride.

Keywords: Prasugrel hydrochloride, RP-HPLC, Forced degradation, UV Detector and Validation.