Determination of clozapine and its major metabolites in serum samples of adolescent schizophrenic patients by high-performance liquid chromatography. Data from a prospective clinical trial

Pharmacopsychiatry. 1995 Jan;28(1):20-5. doi: 10.1055/s-2007-979583.

Abstract

This report describes a method for determination of clozapine and its major metabolites N-desmethylclozapine and clozapine N-oxide in serum samples of adolescent schizophrenic patients during maintenance therapy. The method includes deproteinization and subsequent high-performance liquid chromatography with electrochemical detection. The method shows sufficient sensitivity to quantitate clozapine, clozapine N-oxide and N-desmethylclozapine accurately at 0.5, 5, and 0.5 ng/ml, respectively. We were able to demonstrate for 16 patients receiving fixed doses of clozapine that the individual mean values calculated from six consecutive measurements revealed a strong linear dosage and serum level relationship (Pearson's coefficient of correlation): clozapine (r = 0.82, p = 0.0001); N-desmethylclozapine (r = 0.81, p = 0.0001); clozapine N-oxide (r = 0.91; p = 0.0001). Preliminary pharmacokinetic data are presented and dose-response relationship are discussed.

MeSH terms

  • Administration, Oral
  • Adolescent
  • Adult
  • Body Weight
  • Chromatography, High Pressure Liquid / methods*
  • Clozapine / blood
  • Clozapine / metabolism*
  • Clozapine / pharmacokinetics
  • Dose-Response Relationship, Drug
  • Female
  • Humans
  • Male
  • Schizophrenia / drug therapy*

Substances

  • Clozapine