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目的:对采用液相色谱-串联质谱联用法测定米格列奈的血药浓度进行不确定度评价,以找到影响不确定度的因素,为评价检测报告提供科学依据。方法:根据《测量不确定度评定与表示》,并参考《化学分析中不确定度的评估指南》,对血浆中米格列奈浓度测定进行测量不确定度的分析与评定。结果:10 ng.ml-1米格列奈的标准不确定度为0.289 ng.ml-1,扩展不确定度为0.579 ng.ml-1,浓度测定结果可表示为(9.275±0.579)ng.ml-1。结论:建立的不确定评估方法可用于液相色谱-串联质谱联用法测定血浆中米格列奈浓度的不确定度评估。标准曲线拟合和样品前处理是主要的不确定度来源。测量不确定度的评定方法的确立对于血浆中米格列奈浓度测定方法标准的研究具有重要意义。
OBJECTIVE: To evaluate the uncertainty of plasma concentration of mitiglinide by liquid chromatography-tandem mass spectrometry (LC-MS / MS) in order to find the factors that affect the uncertainty and provide a scientific basis for evaluating the test report. Methods: According to “Evaluation and Expression of Uncertainty in Measurement” and referring to the “Guidance on Evaluation of Uncertainty in Chemical Analysis”, the uncertainty of measurement of mitiglinide in plasma was analyzed and evaluated. Results: The standard uncertainty of 10 ng.ml-1 mitiglinide was 0.289 ng.ml-1, and the extended uncertainty was 0.579 ng.ml-1. The results of concentration determination could be expressed as (9.275 ± 0.579) ng. ml-1. Conclusion: The established uncertainty assessment method can be used to evaluate the uncertainty of plasma concentration of mitiglinide by liquid chromatography-tandem mass spectrometry. Standard curve fitting and sample preparation are the main sources of uncertainty. The establishment of a method for the assessment of measurement uncertainty is of great importance for the study of the standard method for the determination of mitiglinide in plasma.