HPLC测定人血浆中吡非尼酮浓度的不确定度评定

Uncertainty Evaluation on Determination of Pirfenidone in Human Plasma by HPLC

摘要: 目的建立HPLC测定人血浆中吡非尼酮浓度的不确定度分析方法。方法分析HPLC测定吡非尼酮浓度的全过程，分析测量不确定度的来源和大小，量化各个测量不确定度分量，合成标准测量不确定度并报告扩展测量不确定度。结果人血浆中低浓度（0.511 0 mg·mL^-1）、中浓度（2.038 mg·mL^-1）和高浓度（19.95 mg·mL^-1）的扩展不确定度分别为0.105 1，0.137 6，1.069 mg·mL^-1（P=95%）。结论本方法不确定度来自标准曲线的拟合，其适用于HPLC测定人血浆吡非尼酮的不确定度评定。

Abstract: OBJECTIVE To establish the measurement uncertainty in determination of pirfenidone in plasma by HPLC. METHODS The various factors influencing the uncertainty in the whole process of determination, were all analyzed and estimated. The uncertainty of each variable was calculated. The expanded uncertainties and combined uncertainty were analyzed with all the components. RESULTS The expanded uncertainty for low(0.511 0 mg·mL^-1), medium(2.038 mg·mL^-1) and high(19.95 mg·mL^-1) level of pirfenidone were 0.105 1, 0.137 6, 1.069 mg·mL^-1, respectively(P=95%). CONCLUSION The uncertainly of the method is mainly caused by the calibration curve. The method is applicable for the uncertainty evaluation of pirfenidone determination in human plasma by HPLC.