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目的:评定液质联用法(LC-MS/MS)测定人血浆中拉莫三嗪(LTG)浓度的不确定度。方法:分析LC-MS/MS法测定人血浆中LTG浓度过程中的不确定度来源,计算其大小并进行合成。结果:人血浆中LTG低浓度(0.050 4μg·ml~(-1))和高浓度(1.27μg·ml~(-1))的扩展不确定度分别为0.005 18μg·ml~(-1)和0.066 4μg·ml~(-1)(P=95%,k=2)。结论:LC-MS/MS法测定人血浆中LTG浓度的不确定度在低浓度时主要由蛋白沉淀回收率、基质效应和生物样品配制引入,在高浓度时主要由基质效应、生物样品配制和重复性引入。
OBJECTIVE: To assess the uncertainty in the determination of lamotrigine (LTG) concentration in human plasma by liquid chromatography-mass spectrometry (LC-MS / MS). Methods: The sources of uncertainty in the determination of LTG concentrations in human plasma by LC-MS / MS were analyzed, their sizes were calculated and synthesized. Results: The expanded uncertainties of LTG low concentration (0.050 4 μg · ml -1) and high concentration (1.27 μg · ml -1) in human plasma were 0.005 18 μg · ml -1 and 0.066 4 μg · ml -1 (P = 95%, k = 2). CONCLUSION: The uncertainty of LC-MS / MS method for the determination of LTG in human plasma at low concentrations is mainly caused by the recovery of protein precipitates, matrix effects and the preparation of biological samples. At high concentrations, the uncertainty of LTG concentration is mainly determined by the matrix effect, biological sample preparation and Repeatability introduced.