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学科主题临床医学
Accuracy Profile Theory for the Validation of an LC-MS-MS Method for the Determination of Risperidone and 9-Hydroxyrisperidone in Human Plasma
Zhang, Xianhua1; Zhao, Xia2; Zhang, Chao1; Yang, Li1; Xiong, Xin1; Zhou, Yong1; Yang, Yiheng1; Duan, Jingli1
关键词Column liquid chromatography Tandem mass spectrometry Measurement uncertainty Risperidone and 9-hydroxyrisperidone
刊名CHROMATOGRAPHIA
2010-06-01
DOI10.1365/s10337-010-1580-3
71期:11-12页:1015-1023
收录类别SCI
文章类型Article
WOS标题词Science & Technology
类目[WOS]Biochemical Research Methods ; Chemistry, Analytical
研究领域[WOS]Biochemistry & Molecular Biology ; Chemistry
关键词[WOS]PERFORMANCE LIQUID-CHROMATOGRAPHY ; QUANTITATIVE ANALYTICAL PROCEDURES ; PRESSURE CHEMICAL-IONIZATION ; MASS-SPECTROMETRY ; MEASUREMENT UNCERTAINTY ; METABOLITE 9-HYDROXYRISPERIDONE ; ATYPICAL ANTIPSYCHOTICS ; SFSTP PROPOSAL ; SERUM ; QUANTIFICATION
英文摘要

A sensitive and specific LC-MS-MS method is described for the simultaneous quantification of risperidone and 9-hydroxyrisperidone in human plasma. After extraction with tert-butyl methyl ether, plasma samples were separated on an Atlantis HILIC Silica C18 column (4.6 x 150 mm, 5 mu m)with a mobile phase of ammonium formate buffer (10 mM, pH 4.0)/acetonitrile (40/60, v/v). Detection was by MS-MS. The method was fully validated according to the accuracy profile theory. It is based on beta-expectation tolerance interval for the total measurement error which includes trueness and intermediate precision. The measurement uncertainty derived from beta-expectation tolerance interval was estimated at each of the validation standards. The linearity fitted well over the range of 0.11-26.75 ng mL(-1) for risperidone with an LLOQ of 0.11 ng mL(-1), and for 9-hydroxyrisperidone, at a range of 0.15-37.8 ng mL(-1) with an LLOQ of 0.15 ng mL(-1). The intra- and inter-batch precision of risperidone were < 5.71 and 8.22%, respectively. For 9-hydroxyrisperidone, the data were 5.78 and 6.48%. The recoveries were 88.78% (risperidone) and 70.35% (9-hydroxyrisperidone). The developed method was applied to a pharmacokinetic study of risperidone.

语种英语
WOS记录号WOS:000277936600007
引用统计
被引频次:8[WOS]   [WOS记录]     [WOS相关记录]
文献类型期刊论文
条目标识符http://ir.bjmu.edu.cn/handle/400002259/66901
专题北京大学第三临床医学院_药剂科
北京大学第二临床医学院_产科
作者单位1.Peking Univ, Hosp 3, Dept Pharm, Beijing 100191, Peoples R China
2.Peking Univ, Hosp 1, Dept Pharm, Beijing 100034, Peoples R China
推荐引用方式
GB/T 7714
Zhang, Xianhua,Zhao, Xia,Zhang, Chao,et al. Accuracy Profile Theory for the Validation of an LC-MS-MS Method for the Determination of Risperidone and 9-Hydroxyrisperidone in Human Plasma[J]. CHROMATOGRAPHIA,2010,71(11-12):1015-1023.
APA Zhang, Xianhua.,Zhao, Xia.,Zhang, Chao.,Yang, Li.,Xiong, Xin.,...&Duan, Jingli.(2010).Accuracy Profile Theory for the Validation of an LC-MS-MS Method for the Determination of Risperidone and 9-Hydroxyrisperidone in Human Plasma.CHROMATOGRAPHIA,71(11-12),1015-1023.
MLA Zhang, Xianhua,et al."Accuracy Profile Theory for the Validation of an LC-MS-MS Method for the Determination of Risperidone and 9-Hydroxyrisperidone in Human Plasma".CHROMATOGRAPHIA 71.11-12(2010):1015-1023.
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