LC-MS法测定人血浆中人参皂苷Rb_1浓度的不确定度评定

Uncertainty Evaluation on Determination of Ginsenoside Rb_1 in Human Plasma by HPLC

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 evaluate the uncertainty of ginsenoside Rb_1 determination in human plasma by LC- MS.Methods： The uncertainty caused by various factors in the whole process of determination was analyzed. Mathematical model was established for the evaluation of uncertainty to identify influential factors of uncertainty and evaluate the uncertainty factors. The combined uncertainty was calculated and the expanded uncertainty was obtained. Results： The expanded uncertainty for the low（ 4. 73 μg/L）,medium（ 94. 50 μg/L） and high（ 7560 μg/L） levels of ginsenoside Rb_1 was 11. 64 μg/L,15. 42 μg/L and 820. 58 μg/L,respectively（ P = 95%）. Conclusion This method is applicable to uncertainty evaluation of ginsenoside Rb_1 determination in human plasma and the uncertainty of this method was mainly caused by linear regression.