高效液相色谱法测定蒲公英中菊苣酸含量的不确定度评定

Uncertainty Evaluation of Content Determination of Cichoric Acid in Taraxaci Herba by HPLC

目的建立高效液相色谱(HPLC)法测定蒲公英中菊苣酸含量的不确定度评定方法。方法按照2020年版《中国药典(一部)》中蒲公英含量测定方法,建立相应数学模型,找出影响测定不确定度的因素,计算合成标准不确定度和扩展不确定度。结果在95%置信概率情况下,HPLC法测定蒲公英含量的合成标准不确定度为0.01%,扩展不确定度为0.02%,结果表示为(0.14±0.02)%,包含因子(k)为2。结论供试品溶液稀释体积是影响测量结果的主要因素。通过不确定度的评估,可及时发现和控制检验风险环节,提高检验结果的准确性,为检验检测报告质量的合理评价提供可靠依据。

Objective To establish an evaluation method for the content uncertainty of cichoric acid in Taraxaci Herba by the high-performance liquid chromatography(HPLC)method.Methods According to the content determination method of Taraxaci Herba in the Chinese Pharmacopoeia(2020 Edition,VolumeⅠ),a corresponding mathematical model was established to identify the influencing factors of the uncertainty,and the synthetic standard uncertainty and expanded uncertainty were calculated.Results Under the condition of 95%confidence probability,the synthetic standard uncertainty of the HPLC method for the content determination of Taraxaci Herba was 0.01%,the expanded uncertainty was 0.02%,and the result was expressed as(0.14±0.02)%,with a coverage factor(k)of 2.Conclusion The dilution volume of the test solution is the main factor affecting the measurement results.By evaluation of uncertainty,the inspection risk links can be identified and controlled in time,and the accuracy of the inspection results can be improved,which can provide a reliable basis for the reasonable evaluation of the quality of the inspection and testing reports.