A Simple and Effective Stability Indicating Normal Phase HPLC Method for Development and Validation of Clopidogrel Bysulfate Drug Substance

Clopidogrel is a thienopyridine antiplatelet agent that is taken orally. In coronary artery disease, peripheral vascular disease, and cerebrovascular disease, it is used to prevent blood clots. It operates by blocking the P2Y12 receptor in an irreversible manner. In this paper, A Simple and Effective Stability Indicating Normal Phase HPLC Method has been developed and validated for clopidogrel bysulfate drug substance. Chromatographic separation was performed on a Chiral Cel OD-H Column (250 × 4.6 mm, 5p) with a mobile phase of 920 mL n-Hexane, 50 mL Ethanol, 30 mL Isopropyl alcohol, and 0.3 mL diethylamine flowing at 0.9 mL per minute. At 240nm, the detection was made. Clopidogre peak has a retention time of 20.8 minutes. According to the ICH and USP requirements, the proposed approach was validated.