Simultaneous Determination of Prasugrel and its Process Related Impurities and Degradation Products in Bulk Drug Substances by RPLC-UV

Abstract

Aims: This study aims to determine the quantitative prasugrel (PG) and its all possible process-related impurities. Background: To the best of our knowledge, very few analytical methods are available in the literature for monitoring process related impurities and degradation products of PG in bulk drug substance/ active pharmaceutical ingredient (API). Objective: The objective of this study is the separation of Prasugrel and its all possible process-related impurities viz., desacetyl prasugrel-tautomeric forms, intermediates including desacetyl impurity existing in its keto-enol form and positional tautomer impurities with degradation products. Method: A simple and robust HPLC-UV method having Zorbax XDB C18 column (15 cm x 4.6 mm) 3.5μm particle size column was used. Result: Prasugrel and its process related impurities were separated as well as analyzed in pharmaceutical samples' biological matrices. Conclusion: RP-LC method was developed for quantitative determination of PG and related substantial impurities were found to be highly specific, sensitive and precise. The major oxidative degradant was identified as PG desacetyl IMPs (keto-enol and positional tautomer) and hydroxyl IMP.