Sensitive high-performance liquid chromatographic method for the determination of a benzonaphthazepine antipsychotic agent, SCH 39166, and its active metabolite, SCH 40853, in human plasma and its cross-validation with a gas chromatographic method |
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Authors: | Chin-chung Lin Hong-Ki Kim Donald Parker |
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Affiliation: | Departments of Drug Metabolism and Pharmacokinetics, Schering-Plough Research Institute 2015 Galloping Hill Road, Kenilworth, NJ 07033, USA |
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Abstract: | A sensitive high-performance liquid chromatographic (HPLC) method was developed for the determination of a benzonaphthazepine antipsychotic agent, SCH 39166, and its active metabolite, SCH 40853. The HPLC method required a single-step organic extraction at alkali pH followed by HPLC analysis utilizing a CN column with UV detection at 205 nm. The limit of quantitation was 1 ng/ml for SCH 39166 and 0.5 ng/ml for SCH 40853. The HPLC method was cross-validated with a previously reported GC method by the analysis of 73 plasma samples spiked with various concentrations of SCH 39166 and SCH 40853. The correlation coefficient was 0.9969 for SCH 39166 and 0.9984 for SCH 40853. Both GC and HPLC methods were used for the determination of plasma concentrations and yielded similar pharmacokinetic parameters for SCH 39166 and SCH 40853 in man following oral administration of SCH 39166 (100 mg). |
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Keywords: | Benzonaphthazepine antipsychotic |
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