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。
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.In this article,the authors summarized the underlying mechanisms,strategies for assessment,and method for elimination of matrix effect via reviewing the published articles as well as the related guidance issued by FDA and EMEA.
出处
《中国新药杂志》
CAS
CSCD
北大核心
2011年第20期1953-1956,共4页
Chinese Journal of New Drugs
