高效液相色谱法测定保健品水飞蓟片中水飞蓟宾的不确定度评定

Uncertainty evaluation for the determination of silybin in silybin tablets of health food by high performance liquid chromatography

中文关键词:  高效液相色谱法  保健品  水飞蓟宾  不确定度

英文关键词:high performance liquid chromatography  health food  silybin  uncertainty

中文摘要:

      目的 评定高效液相色谱法测定保健品水飞蓟片中水飞蓟宾含量的不确定度。方法 按照《中华人民共和国药典》一部2015版中规定的高效液相色谱法对保健品水飞蓟片中水飞蓟宾含量进行测定,根据JJF 1059.1-2012《测量不确定度评定与表示》对测定过程中影响检验结果的各个分量进行评估。通过对测量重复性、标准品溶液配制、样品溶液的配制、高效液相色谱仪以及标准曲线拟合测量偏差这5个方面引入的不确定度进行分析, 确定各个不确定度分量, 计算扩展不确定度。结果 保健品水飞蓟片中水飞蓟宾含量测定结果为(2.440±0.093) g/100 g, P=95%(k=2)。结论 方法重复性和标准品配制因素对测量不确定度影响最为显著, 需要在实验中进行注意。

英文摘要:

      Objective To evaluate the uncertainty of the determination of silybin content in silybin tablets of health food by high performance liquid chromatography (HPLC). Methods According to the Pharmacopoeia of the people's Republic of China Part 1 2015 Edition and JJF 1059.1-2012 Measurement uncertainty and results indication, each component affecting the test result in the determination process was assessed. Through analyzing the uncertainty introduced from 5 aspects, including the repeatability of determination, the preparation of standard solution, the preparation of sample solution, high performance liquid chromatograph and the measurement deviation of standard curve fitting, each uncertainty component was determined and the expanded uncertainty was calculated. Results The content of silyin in silybin tablets was (2.440±0.093) g/100 g, P=95%(k=2). Conclusion The preparation of standard solution and method repeatability have the most significant influence on the uncertainty of measurement, which need attention in the experiment.