目的 评价高效液相色谱-串联质谱（LC-MS/MS）法检测人血浆依托考昔浓度的不确定度。方法 采用所建立数学模型对影响人血浆依托考昔浓度测定的因素——重复性、称量、溶液配制、标样配制、样品提取、基质效应、线性拟合、仪器量化等，进行量化、合成及扩展。结果 置信概率（P）为95%时，依托考昔低、中、高3质量浓度可分别表示为（33.30±8.61）、（322.0±18.3）、（2 507±140）ng/mL。结论 人血浆依托考昔浓度测定方法不确定度主要来自线性拟合、溶液配制和基质效应。

Objective To evaluate the uncertainty of a new method for the determination of etoricoxib in human plasma. Methods The mathematical model was established, and used to quantify, synthesize and expand the influence factors including precision, weighing, solution preparation, drug-spiked plasma preparation, extraction process, matrix effect, linear fitting and equipment factor in the whole process of determination of etoricoxib in human plasma by the mathematical model. Results When the confidence probability was 95%, the low, medium and high concentrations of etoricoxib in human plasma could be expressed as (33.3±8.61), (322±18.3) and (2 507±140) ng/mL. Conclusion The uncertainty of new method mainly comes from linear fitting, solution preparation and matrix effect.

R917

山东省重点研发计划（2018GSF118130）