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目的:评定HPLC-MS/MS测定人血浆中卡马西平(CBZ)浓度的不确定度。方法:分析HPLC-MS/MS法测定人血浆中CBZ浓度的不确定度来源,计算并进行合成和扩展。结果:人血浆中低浓度(7.46 ng·ml~(-1))和高浓度(745 ng·ml~(-1))CBZ的扩展不确定度分别为0.410 ng·ml~(-1)和33.400 ng·ml~(-1)(P=95%,k=2)。结论:HPLC-MS/MS法测定人血浆中CBZ浓度的不确定度在低浓度时主要由回收率、生物样品配制和基质效应引入,在高浓度时主要由生物样品配制和重复性引入。
OBJECTIVE: To assess the uncertainty of determination of carbamazepine (CBZ) concentration in human plasma by HPLC-MS / MS. Methods: The sources of uncertainty for the determination of CBZ concentrations in human plasma were analyzed by HPLC-MS / MS method, and were calculated and synthesized. RESULTS: The expanded uncertainty of CBZ concentrations in human plasma at low concentrations (7.46 ng · ml -1) and high concentrations (745 ng · ml -1) were 0.410 ng · ml -1 and 33.400 ng · ml -1 (P = 95%, k = 2). CONCLUSION: The uncertainty of determination of CBZ concentration in human plasma by HPLC-MS / MS is mainly introduced by recovery rate, preparation of biological sample and matrix effect at low concentration, mainly by biological sample preparation and repetitive introduction.