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LC-MS~n应用于生物样品检测中基质效应的评价
引用本文:王鹏,蒋学华,王凌. LC-MS~n应用于生物样品检测中基质效应的评价[J]. 中国新药杂志, 2011, 0(20)
作者姓名:王鹏  蒋学华  王凌
作者单位:国家食品药品监督管理局药品审评中心;四川大学华西药学院临床药学与药事管理学系;
摘    要:
液质联用技术具有灵敏度高,特异性强的特点,已被广泛运用于生物样品的分析和检测中。然而基质效应问题往往被忽略,事实上基质效应的存在可能极大影响液质联用技术的准确度和精确度,降低实验数据的可靠性。文中通过查阅和比较美国FDA和欧洲EMEA相关指导原则,探讨基质效应存在的原因和消除基质效应的方法,提出基质效应的评价方法和评价指标,供生物样品分析工作者参考。

关 键 词:液质联用  基质效应  生物样品  指导原则  

Assessment of matrix effect in quantitative bioanalytical methods based on LC-MS~n
WANG Peng,JIANG Xue-hua,WANG Ling. Assessment of matrix effect in quantitative bioanalytical methods based on LC-MS~n[J]. Chinese Journal of New Drugs, 2011, 0(20)
Authors:WANG Peng  JIANG Xue-hua  WANG Ling
Affiliation:WANG Peng1,JIANG Xue-hua2,WANG Ling1,2(1 Center for Drug Evaluation,State Food and Drug Administration,Beijing 100038,China,2 Department of Clinical Pharmacy and Pharmacy Administration,West China School of Pharmacy,Sichuan University,Chengdu 610041,China)
Abstract:
The high-performance liquid chromatography(HPLC) with tandem mass spectrometric(MS/MS) detection has been considered to be of high sensitivity and specificity.Thus,it becomes a powerful technique for the quantitative determination of analytes in biological fluid samples.The matrix effect has been found to be a serious method liability,but lacks attention.In fact,the matrix effect could significantly compromise the method reliability which should be taken into consideration during the assay development phase...
Keywords:LC-MSn  matrix effect  biological fluid sample  guidance  
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