Abstract
A simple chiral liquid chromatographic method for the enantiomeric purity of methyl (2S)-(2-chlorophenyl)-(2-(thiophen-2-yl)ethylamino) acetate—a clopidogrel intermediate—is proposed. Chromatographic separations are carried out isocratically on a chiral amylose-based column (ChiralPAK AD-H) using a mobile phase consisting of hexane/isopropanol/diethylamine, 90/10/0.1, v/v/v. Under the optimum conditions, the resolution between the two isomers was found to be more than 4.5. The method was developed and validated in terms of linearity, precision and accuracy, limit of detection (LOD) and quantitation (LOQ) and robustness. The proposed approach has been successfully applied to bulk samples for evaluating enantiomeric purity.
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