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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 HPLC method for the determination of paeonol dropping pills and analyze the uncertainty of measurement. METHODS: A mathematical model was established for the determination of paeonol content by HPLC, and the main factors affecting the uncertainty were identified and evaluated for each uncertainty component. Results: Uncertainty and synthetic uncertainty of each variable were calculated. The determination result of paeonol dropping pills was 164.77mg.g-1, and the expanded uncertainty was 6.00mg.g-1 (k=2). Conclusion: The uncertainty evaluation method established in this experiment is suitable for the evaluation of the uncertainty of the determination of active ingredient content of solid formulations by HPLC.