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目的:建立液相色谱-串联质谱(LC-MS/MS)法测定人血浆中比拉斯汀浓度的方法,并对其方法不确定进行评定.方法:对测定人血浆中比拉斯汀的浓度过程中的不确定度来源进行分析,包括测定精密度、仪器、称量、标准溶液配制、含药血浆配制、标准曲线拟合、血浆样本的处理等,计算各分量的不确定度和合成不确定度,最终计算扩展不确定度.结果: 低(15 ng ·ml-1)、中(400 ng·ml-1)、高(1 200 ng·ml-1)各浓度的扩展不确定度分别为1. 45 ng·ml-1、28. 72 ng·ml-1、74. 61 ng· ml-1(k=2, P=95% ).结论:人血浆中比拉斯汀含量的不确定度主要是由仪器允差,标准溶液的配制,血浆样本的处理,标准曲线拟合(低浓度)引入.“,”Objective: To establish a method for the determination of bilastine in human plasma, and evaluate the uncertainty by LC-MS/MS. Methods: The uncertainty sources were obtained from the whole process of the determination including repeatability, e-quipment error, weighting, solution preparation, calibration fitting and plasma sample handling. The uncertainty and synthesized un-certainty of each component were calculated, and then the expanded uncertainty was obtained. Results: The expanded uncertainty for low (15 ng·ml-1), medium (400 ng·ml-1) and high(1 200 ng·ml-1) level of bilastine was 1. 45 ng·ml-1, 28. 72 ng·ml-1 and 74. 61 ng·ml-1, respectively (k=2, P=95% ). Conclusion: The uncertainty in the determination of bilastine in human plasma is mainly caused by equipment error, solution preparation, protein precipitation and calibration fitting (especially at low level).