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目的:评定LC-MS法测定人血浆中人参皂苷Rb_1浓度的不确定度。方法:对LC-MS法测定人血浆中人参皂苷Rb_1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(4.73μg/L)、中(94.50μg/L)、高(7 560μg/L)浓度人参皂苷Rb_1的扩展不确定度分别为11.64、15.42、820.58μg/L。结论:本方法适用于LC-MS法测定人血浆中人参皂苷Rb_1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 Rb 1 in human plasma by LC-MS. Methods: The whole process of determination of ginsenoside Rb_1 in human plasma by LC-MS method was analyzed. The mathematical model was established to evaluate the uncertainty, determine the factors that affect the uncertainty, evaluate each factor and calculate the synthetic uncertainty Expand. Results: The extended uncertainty of the concentrations of Ginsenoside Rb 1 at low (4.73 μg / L), medium (94.50 μg / L) and high (7 560 μg / L) concentrations was 95% 820.58 μg / L. Conclusion: The method is suitable for the determination of the uncertainty of the concentration of ginsenoside Rb_1 in human plasma by LC-MS. The uncertainty is mainly introduced by linear regression.