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目的:分析HPLC法测定利胆排石片中大黄酚和大黄素含量的不确定度。方法:通过建立HPLC法测定含量的数学模型,找出影响不确定度的因素,并对各个不确定度因素进行评估、计算,由此计算合成不确定度,最终给出测量结果的扩展不确定度和置信水平。结果:大黄酚和大黄素合成不确定度分别为0.139、0.108;扩展不确定度大黄酚和大黄素分别为0.11%、0.05%;利胆排石片大黄酚含量(%)测定结果为(0.52±0.11)%、大黄素含量(%)测定结果为(0.25±0.05)%。结论:建立HPLC法的不确定度分析与计算方法适用于片荆HPLC法含量测定不确定度评定。
OBJECTIVE: To analyze the uncertainty of HPLC method for the determination of chrysophanol and emodin in Lixia Pai tablet. Methods: By establishing a mathematical model of content determination by HPLC, find out the factors that affect the uncertainty and evaluate and calculate the factors of uncertainty, then calculate the synthesis uncertainty and finally give the uncertainty of the expansion of measurement results Degree and confidence level. Results: The uncertainty of synthesis of chrysophanol and emodin were 0.139 and 0.108, respectively. The uncertainty of expansion of chrysophanol and emodin were 0.11% and 0.05% respectively. The determination of chrysophanol content (% ± 0.11)%, and the emodin content (%) was (0.25 ± 0.05)%. Conclusion: The establishment of HPLC method of uncertainty analysis and calculation method is suitable for HPLC determination of content of HPLC method to assess the uncertainty.