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目的:评定LC-MS法测定人血浆中人参皂苷Rg1浓度的不确定度。方法:对LC-MS法测定人血浆中人参皂苷Rg1浓度的全过程进行分析,建立数学模型评定其不确定度,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(2.55μg/L)、中(50.90μg/L)、高(814.40μg/L)浓度人参皂苷Rg1的扩展不确定度分别为7.24μg/L、9.32μg/L及98.50μg/L。结论:本方法适用于LC-MS法测定人血浆中人参皂苷Rg1浓度的不确定度评定,不确定度主要由线性回归过程引入。
OBJECTIVE: To assess the uncertainty of determination of ginsenoside Rg1 in human plasma by LC-MS. Methods: The whole process of determination of ginsenoside Rg1 in human plasma by LC-MS method was analyzed. The mathematic model was established to evaluate the uncertainty, determine the factors that affect the uncertainty and evaluate the various factors of uncertainty. Confirm and expand. Results: The extended uncertainty of the concentrations of ginsenoside Rg1 at low (2.55μg / L), medium (50.90μg / L) and high (814.40μg / L) concentrations in plasma was 95% , 9.32 μg / L and 98.50 μg / L respectively. Conclusion: This method is suitable for the determination of the uncertainty of the concentration of ginsenoside Rg1 in human plasma by LC-MS. The uncertainty is mainly introduced by linear regression.