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The Validation of an LC-MS Method for the Determination of Risperidone and its Active Metabolite 9-Hydroxyrisperidone in Human Plasma
Authors:Li Zhang  Zheng Jiao  Zouqing Yao  Yan Zhong  Mingkang Zhong  Yunqiu Yu
Institution:(1) Department of Pharmaceutical Analysis, School of Pharmacy, Fudan University, 200032 Shanghai, China;(2) Department of Pharmacy, Hushan Hospital, Fudan University, 200040 Shanghai, China
Abstract:A simple, specific and sensitive high performance liquid chromatography-mass spectrometry (LC-MS) method for the determination of risperidone and its active metabolite 9-hydroxyrisperidone in human plasma has been developed and validated. The analytes were prepared through a single-step liquid-liquid extraction (LLE) procedure with the solvent methyl tert-butyl ether and quantitated by MS detection in the positive mode using selected ion monitoring (SIM). Each analytical run was completed within 9 min. Results showed that the LC-MS method enabled to detection of both compounds down to 0.1 ng.mL–1 (S/N > 3) and the linear range was 0.2–24 ng.mL–1, with the correlation coefficients above 0.99. At the concentration of 0.2, 0.5, 10 and 20 ng.mL–1, the inter-day and intra-day RSD were both below 15%. The method has been successfully used to support the routine therapeutic drug monitoring (TDM) and the pharmacokinetics study of risperidone.
Keywords:Column liquid chromatography-mass spectrometry  Risperidone and 9-hydroxyrisperidone  Human plasma samples
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