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目的:评定LC-MS法测定血浆中麦冬皂苷D’浓度的不确定度。方法:对测定方法的全过程进行分析,建立评定其不确定度的数学模型,确定影响不确定度的因素并对各个不确定度因素进行评估,计算合成不确定度并进行扩展。结果:置信概率P为95%时,血浆中低(35.10μg/L)、中(280.80μg/L)、高(702.00μg/L)浓度麦冬皂苷D’的扩展不确定度分别为:6.22、7.64、76.50μg/L。结论:本方法适用于LC-MS法测定人血浆中麦冬皂苷D’浓度的不确定度评定。
OBJECTIVE: To assess the uncertainty of determination of the concentration of Ophiopogon japonicus D ’in plasma by LC-MS. Methods: The whole process of the measurement method was analyzed, the mathematical model of evaluating the uncertainty was established, the factors affecting the uncertainty were determined, the factors of each uncertainty were evaluated, the synthesis uncertainty was calculated and extended. Results: The uncertainty of expansion of Ophiopogon japonicus D ’in low plasma (35.10μg / L), medium (280.80μg / L) and high (702.00μg / L) concentrations was 95% , 7.64, 76.50 μg / L. Conclusion: This method is suitable for the uncertainty assessment of the concentration of Ophiopogon japonicus D ’in human plasma by LC-MS.