Direct analysis of the enantiomers of mexiletine and its metabolites in plasma and urine using an HPLC-CSP.

A high-performance liquid chromatographic assay has been developed for the quantification of the enantiomers of mexiletine and its four major metabolites, in plasma and in urine. Mexiletine and all metabolites were determined, after derivatization of mexiletine and its hydroxymetabolites, p-hydroxymexiletine and hydroxymethylmexiletine, using a Chiralpak AD chiral stationary phase, based on a carbamoyl derivative of amylose. o-phthalaldehyde was chosen as derivatization reagent to increase the sensitivity of detection, to achieve separation of all compounds in one chromatographic system, and to avoid interferences.