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目的:建立HPLC法测定人血浆中吗替麦考酚酸浓度的不确定度分析方法。方法:建立HPLC法测定含量的数学模型,分析测量不确定度的来源,量化各个测量不确定度分量,合成标准测量不确定度,给出扩展测量不确定度报告。结果:高、中、低3个浓度的扩展不确定度分别为0.052,0.156,1.96μg·ml~(-1)。结论:该方法适用于HPLC法测定血浆吗替麦考酚酸的不确定度评定,为用HPLC法测定血浆浓度的不确定度评定提供了重要参考。
Objective: To establish an HPLC method for the determination of mycophenolic acid in human plasma uncertainty analysis. Methods: The mathematical model of content determination by HPLC was established, the sources of measurement uncertainty were analyzed, the components of measurement uncertainty were quantified, the standard measurement uncertainty was synthesized, and the report of extended measurement uncertainty was given. Results: The extended uncertainty of high, medium and low concentrations were 0.052,0.156 and 1.96μg · ml -1, respectively. Conclusion: This method is suitable for the determination of plasma mycophenolic acid in plasma by HPLC. It provides an important reference for the evaluation of the uncertainty of plasma concentration by HPLC.