丹皮酚滴丸含量测定不确定度评定

Evaluation of uncertainty measurement in assay of Paeonol Dripping Pills

目的:建立HPLC法测定丹皮酚滴丸含量,并对测量不确定度进行分析。方法:通过建立HPLC法测定丹皮酚含量的数学模型,找出影响不确定度的主要因素并对各不确定度分量进行评估。结果:计算各变量不确定度及合成不确定度,本次丹皮酚滴丸含量测定结果为164.77mg.g-1,其扩展不确定度为6.00mg.g-1(k=2)。结论:本试验建立的不确定度评估方法适用于HPLC法测定固体制剂有效成分含量的不确定度评定。

Objective：To establish a method for uncertainty analysis in HPLC determination for Paeonol Dripping Pills.Methods：The calculation formula of uncertainty was deduced in the procedure of determining Paeonol in Dripping Pills.Results：Each component of uncertainty was calculated among the procedures,and combined uncertainty was finally obtained.The content of Paeonol in Dripping Pills is 164.77 mg·g-1,and the expanded uncertainty was 6.00 mg·g-1（k=2）.Conclusion：The mathematic model established here is suitable for uncertainty analysis for HPLC assay.