Identification and Synthesis of Impurities Formed During Prasugrel Hydrochloride Preparation

Abstract

Prasugrel hydrochloride (1), an important platelet inhibitor is used for the reduction of thrombotic cardiovascular events. During laboratory optimization and later its bulk synthesis the formation of various impurities was observed. The impurities formed were monitored and their structures were tentatively assigned on the basis of their fragmentation patterns in LC-MS. Most of the impurities were synthesized and their assigned constitutions confirmed by co-injection in HPLC. We describe herein the formation, synthesis and characterization of these impurities. Present study will be of immense help to others to obtain chemically pure prasugrel hydrochloride.