Determination of risperidone and 9-hydroxyrisperidone in human plasma by high-performance liquid chromatography: application to therapeutic drug monitoring in Japanese patients with schizophrenia.

Department of Pharmacy, Hirosaki University Hospital, Japan.
Journal of Pharmaceutical and Biomedical Analysis (Impact Factor: 2.95). 04/1999; 19(3-4):595-601. DOI: 10.1016/S0731-7085(98)00261-1
Source: PubMed

ABSTRACT A high-performance liquid chromatographic method has been developed for the simultaneous determination of risperidone and its major active metabolite 9-hydroxyrisperidone in plasma. Risperidone and 9-hydroxyrisperidone in plasma were extracted using a CN bonded-solid phase cartridge, followed by, C4 reversed-phase HPLC separation. Risperidone, 9-hydroxyrisperidone and trazodone as an internal standard were detected by ultraviolet absorbance at 280 nm. It was possible to determine risperidone in the concentration range of 1.0-100.0 ng/ml(-1) and 9-hydroxyrisperidone at a range of 2.0-200.0 ng/ml(-1). The detection limits of risperidone and 9-hydroxyrisperidone were 0.5 and 1.0 ng/ml(-1), respectively. The mean recoveries of risperidone and 9-hydroxyrisperidone added to plasma were less than 92.0 and 92.6%, with a coefficient of variation of less than 10.6 and 10.5%, respectively. This method has been used for the simultaneous determination of steady-state plasma concentration (Css) of risperidone and 9-hydroxyrisperidone in schizophrenic patients treated with 3-, 6-, and 12-mg risperidone oral doses per day.

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