World Journal of
Pharmaceutical and Life Sciences

SEPARATION AND DETERMINATION OF PROCESS-RELATED IMPURITIES OF CLOPIDOGREL BISULPHATE BY RP-HPLC

Rajkumar Prava*, Ganapathy Seru, Jayapal Reddy Sama,
Arun Satyadev Sidhhanadham

ABSTRACT

Clopidogrel bisulfate is a potent oral antiplatelet agent. Pro-drug which belongs to the chemical family of Thienopyridine adenosine diphosphate(ADP)-receptor antagonists.[1-2] It is mainly used to reduce atherosclerotic events like myocardial infarction, stroke and vascular death in patients who had a recent stroke, myocardial infarction or have established peripheral vascular disease. The main objective of the present study is to separate Clopidogrel bisulphate and its process related impurities in the drug substance. In order to develop a suitable and robust RP-HPLC method for the determination of Clopidogrel bisulphate and its process related impurities, an attempt was made with a C18 column using mobile phase composed of acetonitrile and water in the ratio 50:50% v/v. Experiments were conducted by using different columns, different buffers and different concentrations of organic modifier in order to optimize the chromatographic conditions. Reasonable separation between all compounds was observed in case of Clopidogrel bisulphate. It was felt necessary to carry out further optimization studies and hence attempts were made in this direction. Finally, a mobile phase composed of potassium dihydrogen phosphate buffer (pH 3.5) and acetonitrile in the ratio 78:22% v/v with a flow rate of 1.0 ml/min gave sharp peaks with minimum tailing and good resolution for both the drug and its impurities.

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