Enantioselective analysis of cetirizine in pharmaceuticals by cyclodextrin-mediated capillary electrophoresis.

The present paper demonstrates the potential of cyclodextrin (CD)-mediated CE for the chiral analysis of a drug of zwitterionic nature, viz. cetirizine (CET). Various separation mechanisms were applied and several parameters affecting the separation were studied, including the type and concentration of chiral selector, coselector, and carrier ion, and pH of buffer. The optimal separation conditions were based on a medium buffer pH (approximately 5.2) (migration velocity of CET molecule was near to zero) and a highly substituted CD derivative, sulfated-beta-CD, serving as an analyte carrier in the anionic regime of the separation with suppressed electroosmotic flow. In this way, a baseline enantioseparation, reasonable separation efficiency, and short analysis time could be easily achieved. Acceptable validation criteria for sensitivity, linearity, precision, accuracy, and robustness were obtained using a hydrodynamically closed CE separation system. The proposed method was successfully applied to the enantioselective assay of CET in pharmaceutical formulations using fexofenadine (FEX) as an internal standard.