Stability-indicating liquid chromatography for determination of clopidogrel bisulfate in tablets : application to content uniformity testing

Abstract EN

The present study describes a simple stability-indicating reversed-phase HPLC assay for antiplatelet drug, clopidogrel bisulfate.

Separation of the drug and the degradation products, under stress conditions was successfully achieved on a C-18 column utilizing 0.01 M Na2HPO4 (pH 4): acetonitrile in the ratio 80:20 v/v, pumped at a flow rate of 0.5 ml min_1 with UV detection at 235 nm.

The retention time of clopidogrel was 6.84 min.

The method was satisfactorily validated with respect to linearity, precision, accuracy, selectivity, sensitivity and ruggedness.

The response was linear in the range of 0.2-3.5 lg ml_1 with detection limit 0.079 lg ml_1.

The suggested method was successfully applied for the analysis of clopidogrel in bulk and in commercial tablets.

The results were favorably compared to those obtained by a reference method.

The proposed method was successfully applied to the content uniformity testing of tablets and for determination of clopidogrel in presence of its co-administered drug, acetyl salicylic acid.