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学科主题: 临床医学
题名:
Accuracy Profile Theory for the Validation of an LC-MS-MS Method for the Determination of Risperidone and 9-Hydroxyrisperidone in Human Plasma
作者: 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
发表日期: 2010-06-01
DOI: 10.1365/s10337-010-1580-3
卷: 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
Citation statistics:
内容类型: 期刊论文
URI标识: http://ir.bjmu.edu.cn/handle/400002259/66901
Appears in Collections:北京大学第三临床医学院_药剂科_期刊论文

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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

Recommended Citation:
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.
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