The comparison of two validated high performance liquid chromatography (HPLC) methods for the determination of chemical impurities and enantiomeric purity of (+)-clopidogrel hydrogensulfate with the USP method is presented.

The determination using the developed methods were performed on Nova-Pak Phenyl and Chiral AGP columns. The selectivity of the method of chemical impurities determination was demonstrated for 6 analytes: impurity A (RRT 0.5), D (RRT 0.7), B (RRT 1.3), E (RRT 1.7), substrate Cl-5 (RRT 0.4) and clopidogrel. Method for chemical impurities determination and method for chiral analysis are linear with R² = 0.999 and R² = 0.996 and precise with RSD 1.4 % and 2.3, respectively. The LOQ and LOD were calculated respectively on the 0.02 % and 0.006 % for chemical impurities and LOQ = 0.3 % for (-)-clopidogrel determination. Both methods are not affected by broad range of changes of chromatographic parameters, thus proving their robustness.

The developed method for chiral analysis allows to obtain the results as good as using USP method. However, concerning the chemical impurities determination the developed method presents much better selectivity than USP method.

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