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Indian J Pharm Sci. 2008 Sep;70(5):667-9. doi: 10.4103/0250-474X.45414.

Concurrent Estimation of Clopidogrel Bisulfate and Aspirin in Tablets by Validated RP-HPLC Method.

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1
Department of Pharmaceutics, Institute of Technology, Banaras Hindu University, Varanasi-221 005, India.

Abstract

A simple, rapid, precise RP-HPLC method was developed for simultaneous estimation of aspirin and clopidogrel bisulphate in tablet dosage form used in the treatment of cardiovascular diseases. To achieve the maximum resolution, acetonitrile:50 mM potassium dihydrogen phosphate buffer:methanol, solution pH adjusted to 3, in the ratio 50:30:20; v/v was selected as mobile phase. This mixture was found to be appropriate allowing good separation of both the components at a flow rate of 1.5 ml/min and detection wavelength 240 nm. In these conditions clopidogrel bisulfate and aspirin were eluated at the 7.47 and 2.2 min. The linearity was found in the concentration range 1.5-7.5 and 3.5-15.0 μg/ml, respectively. All the analytical validation parameters were determined and found with in the limit as per ICH guideline, which indicates the validity of method.

KEYWORDS:

ICH guidelines; Reverse phase High Performance Liquid Chromatography (RP-HPLC); aspirin; clopidogrel; method validation

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