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Clinical Chemistry 39: 1656-1659, 1993;
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Clinical Chemistry, Vol 39, 1656-1659, Copyright © 1993 by American Association for Clinical Chemistry

Determination of clozapine, norclozapine, and clozapine-N-oxide in serum by liquid chromatography

SA Volpicelli, F Centorrino, PR Puopolo, J Kando, FR Frankenburg, RJ Baldessarini and JG Flood
Department of Pathology, Massachusetts General Hospital, Boston 02114.

We report a new assay to measure the serum concentrations of the atypical antipsychotic drug clozapine and two major metabolites, norclozapine and clozapine-N-oxide. The analytes and an internal standard (triprolidine) were extracted from alkalinized samples into ethyl acetate and back-extracted into 0.1 mol/L HCl. The acid extracts were chromatographed on a reversed-phase liquid chromatographic column with photodiode array detection (210-340 nm). With the 254-nm signal, between-run imprecision (CV) was < 2% for clozapine and norclozapine at 400 micrograms/L, and 4.1% for clozapine-N-oxide at 100 micrograms/L. Absolute recovery exceeded 65%, and the detection limit was approximately 3-4 micrograms/L. In 25 patients at steady state at a mean daily clozapine dosage of 269 mg (3.09 mg/kg), clozapine averaged 231 +/- 144 micrograms/L (mean +/- SD); norclozapine and clozapine-N- oxide concentrations averaged 84% and 23% that of clozapine. Analyte concentrations were significantly correlated with daily dose. The method's ability to quantify clozapine and two major metabolites simultaneously with precision and sensitivity makes it useful in pharmacokinetic studies and therapeutic monitoring.


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 Drug Metab. Dispos.Home page
J. G. Dain, J. Nicoletti, and F. Ballard
Biotransformation of Clozapine in Humans
Drug Metab. Dispos., May 1, 1997; 25(5): 603 - 609.
[Abstract] [Full Text]


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Copyright © 1993 by the American Association for Clinical Chemistry.