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目的:评定LC-MS/MS法测定人血浆中左舒必利含量的不确定度。方法:对测定过程中不确定度的来源进行分析评定,包括称量、纯度、仪器误差、标准溶液的配制、含药血浆样本的配制、标准曲线拟合、重复性、血浆样本的处理等,分析各分量的不确定度与合成不确定度,最终计算扩展不确定度。结果:人血浆中低(9.0 ng·ml~(-1))、中(150.0 ng·ml~(-1))、高(3 200.0 ng·ml~(-1))3个浓度的扩展不确定度分别为2.46,10.42,173.77 ng·ml~(-1)(k=2,P=95%)。结论:LC-MS/MS法测定人血浆中左舒必利含量的不确定度主要由血浆样本的处理,仪器误差、标准溶液的配制及标准曲线拟合(低浓度)引入。
OBJECTIVE: To assess the uncertainty of the LC-MS / MS method for determining the content of zusulpride in human plasma. Methods: The source of uncertainty in the determination process was analyzed and evaluated, including weighing, purity, instrument error, preparation of standard solution, preparation of drug-containing plasma samples, calibration curve fitting, repeatability and plasma sample processing, Analyze the components of the uncertainty and the synthesis of uncertainty, the final calculation of extended uncertainty. Results: The three plasma concentrations of low (9.0 ng · ml -1), medium (150.0 ng · ml -1) and high (3 200.0 ng · ml -1) The determinations were 2.46,10.42,173.77 ng · ml -1 (k = 2, P = 95%). Conclusion: The uncertainty of LC-MS / MS method for the determination of Zusulpride in human plasma is mainly caused by the processing of plasma sample, the error of instrument, the preparation of standard solution and the standard curve fitting (low concentration).