HPLC法测定醋酸泼尼松片含量的测量不确定度评定

Uncertainty Evaluation on Uncertainty Measurement in Content Determination of Prednisone Acetate Tablets by HPLC

目的对高效液相色谱法(HPLC)测定醋酸泼尼松片中醋酸泼尼松含量的不确定度进行分析和评价。方法通过建立醋酸泼尼松含量测定的数学模型,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。结果醋酸泼尼松片含量测定结果可表示为(99.16%±1.0%)(k=2)。结论本文所建立的方法适用于该制剂含量的不确定度评定。

Objective To evaluate and analyze high performance liquid chromatography （HPLC） in uncertainty detection of Prednisone Acetate content in Prednisone Acetate tablets. Methods The uncertainty causes of influencing factors were found out and uncertainty components were also evaluated by establishing detected uncertainty calculation formula. Results The expression of the results of the content determination of Prednisone Acetate Tablets was （99.16 %±1.0 %）（k=2） .Conclusion： The method of evaluation of uncertainty measurement established in this paper is reasonable and reliable.