高效液相色谱法测定白芍总苷的不确定度分析

Uncertainty Analysis for Total Glucosides of Paeony with High Performance Liquid Chromatography Method

目的:建立高效液相色谱法同时测定白芍总苷中的芍药苷和芍药内酯苷的不确定度评定方法。方法:采用高效液相色谱法测定芍药苷和芍药内酯苷含量,分析影响其不确定度的因素来源,对各个不确定度因素进行评定,并计算合成不确定度,最终给出测量结果的扩展不确定度和置信水平。结果:不确定度评估芍药苷为±1.48%、芍药内酯苷为±0.66%。结论:方法可用于高效液相色谱法测定药物含量的不确定度分析,使测定结果更加可靠。

Objective：To establish a high performance liquid chromatography method for uncertainty analysis of paeoniflorin and albiflorin of TGP.Method： HPLC method was established to determine the content of paeoniflorin and albiflorin.Each active component of uncertainty was calculated the variable parameters among the procedures.The combined uncertainty and extended uncertainty and confidence were finally obtained by synthesized the uncertainties of various component variables.Result： Uncertainty evaluation for paeoniflorin was ±1.48% and albiflorin is ±0.66%.Conclusion：The established mathematic model is reasonable and relible,it is applicable to the uncertainty analysis of high performance liquid chromatography method in the determination of drugs.