Analysis of clozapine and norclozapine by high-performance liquid chromatography.
1997; National Institutes of Health; Volume: 696; Issue: 2 Linguagem: Inglês
Autores Tópico(s)
Pharmacogenetics and Drug Metabolism
ResumoA simple and reliable method for analyzing the concentrations of clozapine and its biologically active metabolite, norclozapine, in human serum or plasma has been developed. This method is based on reversed-phase high-performance liquid chromatography (HPLC) with automated solid-phase extraction (SPE). For HPLC analysis, samples and standards are prepared with an ASPEC automatic sample preparator using 100 mg Bond-Elut C18 SPE columns. The HPLC assay is an isocratic method with a mobile phase of acetonitrile-methanol-10 mM dipotassium hydrogenphosphate, pH 3.7 (30:2:100, v/v/v) at a flow-rate of 1.5 ml/min with a C8 reversed-phase column. Detection is performed with a diode array detector set at 220 nm and with peak purity analyses at 210-365 nm. The absolute recovery varied from 85 and 95%. The intra-assay coefficients of variation (C.V.s) were from 4.2 to 8.0% and the inter-assay C.V.s were from 1.1 to 9.3% at therapeutic drug concentrations. The detection limit is 15 nmol/l. The method has been developed for use in a clinical laboratory for therapeutic drug monitoring.
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