HPLC法测定人血浆中法罗培南浓度的不确定度

Uncertainty Evaluation on Determination of Faropenem in Human Plasma by HPLC

目的对人血浆中法罗培南浓度HPLC法测定的不确定度进行评定。方法对HPLC法测定人血浆中法罗培南浓度全过程进行分析。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。结果置信概率为95%时,血浆低、中、高法罗培南的扩展不确定度分别为0.01607、0.09807、0.02709μg.ml-1。结论该方法适用于HPLC法测定血浆中法罗培南浓度的不确定度评定,为复杂生物基质分析过程中的不确定度评定提供了重要参考依据。

Objective To evaluate the uncertainty of farpenem in human plasma by HPLC. Methods The uncertainty caused by various factors in the whole process of determination was analysed. Each active component of uncertainty was calculated, and the extended uncertainty was obtained. Results The expanded uncertainty for the low, medium and high level of farpenem was 0. 01607, 0. 09807, 0. 02709 p,g .m1-1 , respectively（ P =95% ）. Conclusion This method is applicable to uncertainty evaluation of farpenem determination in human plasma, provi- ding important reference for uncertainty evaluation for determination in complex bio-matrix.