Therapeutic drug monitoring of antiepileptics by capillary electrophoresis: Characterization of assays via analysis of quality control sera containing 14 analytes

Quality assurance is an important aspect in therapeutic drug monitoring (TDM). Capillary electrophoresis (CE) assays for determination of (i) ethosuximide via direct injection of serum or plasma, (ii) lamotrigine after protein precipitation by acetonitrile and analysis of an aliquot of the acidified supernatant, and (iii) carbamazepine and carbamazepine-10,11-epoxide after solute extraction followed by analysis of the reconstituted extract are characterized via analysis of a large number of commercial quality control sera containing up to 14 analytes (9 of them are anticonvulsants) in sub-therapeutic, therapeutic and toxicologic concentration levels. CE data obtained in single determinations are shown to compare well with the spike values and the mean of data determined in other laboratories using immunoassays and/or high-performance liquid chromatography, values that are reported by the external quality control scheme. Carbamazepine and ethosuximide drug levels are also shown to agree well with those determined in our departmental drug assay laboratory using automated immunoassays. The presented data reveal the effectiveness of assay assessment via analysis of quality control sera and confirm the robustness of the assays for TDM in a routine setting.