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目的:评价液质联用(HPLC-MS/MS)测定人血浆中来曲唑浓度方法的测量不确定度方法:对HPLC-MS/MS法测定血浆中来曲唑浓度的全过程进行分析分析测量不确定度的来源,用A类评定程序评价分析过程中随机效应引起的不确定度,用B类评定程序评价其他因素引起的不确定度,量化各个不确定度分量,最后根据各分量计算出合成标准测量不确定度,并给出扩展测量不确定度报告结果:置信概率P为95%时,血浆高(79.28 ng·ml~(-1))、中(8.378 ng·ml~(-1))、低(0.099 97 ng·ml~(-1))三个浓度的扩展不确定度分别为3 99,0.417,0.035 32 ng·ml~(-1)。结论:本方法不确定度主要来自标准曲线的拟合过程,其适用于HPLC-MS/MS法测定血浆来曲唑的不确定度评定,为用HPLC-MS/MS法测定血浆浓度的不确定度评定提供了重要参考。
OBJECTIVE: To evaluate the measurement uncertainty of the method for the determination of letrozole in human plasma by liquid chromatography-mass spectrometry (HPLC-MS / MS). Methods: The whole process of determination of letrozole in plasma by HPLC-MS / MS method was analyzed The sources of uncertainty were measured, the uncertainty caused by random effects in the evaluation process was evaluated by the evaluation program of type A, the uncertainty caused by other factors was evaluated by the evaluation program of type B, the components of each uncertainty were quantified, and finally the components were calculated according to the components The results show that when the confidence probability P is 95%, the plasma concentration is high (79.28 ng · ml -1) and the median (8.378 ng · ml -1) 1), and low (0.099 97 ng · ml -1) concentrations were 3 99,0.417,0.035 32 ng · ml -1, respectively. Conclusion: The uncertainty of this method mainly comes from the fitting process of standard curve. It is suitable for the evaluation of the uncertainty of plasma letrozole by HPLC-MS / MS. It is the uncertainty for the determination of plasma concentration by HPLC-MS / MS Degree assessment provides an important reference.