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目的超高效液相色谱(UPLC)法评价人血浆中阿司匹林(ASP)浓度的不确定度。方法分析UPLC法测定人血浆中阿司匹林浓度的整个过程、不确定度来源,最后计算、合成和扩展。结果阿司匹林在最低定量下限浓度(0.44μg·m L~(-1))和高质控浓度(79.71μg·m L~(-1))的扩展不确定度分别为0.03μg·m L~(-1)和8.28μg·m L~(-1)(P=95%,k=2)。结论 UPLC法测定人血浆中阿司匹林的浓度的不确定度,在最低定量下限和高质控浓度时主要由回收率、生物样品配制和重复性引入。
Objective To evaluate the uncertainty of aspirin (ASP) concentration in human plasma by ultra performance liquid chromatography (UPLC). Methods The whole process of determining the concentration of aspirin in human plasma by UPLC method was analyzed, and the sources of uncertainty were calculated and finally calculated, synthesized and expanded. Results The extended uncertainty of aspirin in the lowest limit of quantitation (0.44μg · m L -1) and high concentration (79.71μg · m L -1) were 0.03μg · m L ~ (-1) -1) and 8.28 μg · m L -1 (P = 95%, k = 2). Conclusion The uncertainty of determination of aspirin concentration in human plasma by UPLC method was mainly introduced by recovery rate, biological sample preparation and repeatability at the lowest limit of quantification and high quality control concentration.