Abstract

A VALIDATED RP-HPLC METHOD FOR PRASUGREL HYDROCHLORIDE

D. Pavan Kumar*, T. Naga Jhansi, G. Srinivasa Rao and Kirti Kumar Jain

ABSTRACT

Prasugrel hydrochloride, (2S)-4-Oxo-[3-(trifluromethyl)-5,6-dihydro[1,2,4]triazolo [4,3-α] pyrazine-7(8H)-yl]-1-(2,4,5-trifluorophenyl)butane-2-amine is a platelet inhibitor and an irreversible antagonist of P2Y12 ADP receptors and is used for the treatment of heart patients to prevents from forming harmful blood clots. Several bio-analytical and analytical methods have been reported for the analysis of Prasugrel hydrochloride. Recently stability indicated related substance by HPLC method was published in European Pharmacopoeia and United States Pharmacopeia, with six potential impurities.[1-2] Three of the in-house process impurities were not separated by pharmacopeia method. So, comprehensive study was taken to develop a single method for all these impurities and it should be stability indicating method. In this newly developed HPLC method included three in-house impurities other than the listed pharmacopeia impurities. This method is accurate, linear, specific, reproducible and stability indicating HPLC method with good Limit of Quantification and Limit of Detection of Prasugrel hydrochloride and its related impurities.

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