HPLC法测定片剂中双氢青蒿素含量的不确定度评估

分析HPLC法测定双氢青蒿素哌喹片中双氢青蒿素含量的不确定度构成及其大小。通过对不确定度分量进行分析和评定,计算含量测定中各条件的合成不确定度和扩展不确定度。最终得出扩展不确定度U=0.8 mg(k=2)。HPLC法测定双氢青蒿素哌喹片中双氢青蒿素含量的不确定度评估中供试品溶液色谱峰面积所引起的不确定度分量对合成不确定度影响最大。

Uncertainty of the Determination of Dihydroartemisinin in Dihydroartemisinin and Piperaquine Phosphate Tablets with HPLC

The components and degree of the uncertainty of determination of dihydroartemisinin in Dihydroartemisinin and Piperaquine Phosphate tablets by HPLC are analyzed.The degree of synthesizing uncertainty and the expanded uncertainty under all conditions for component determination was calculated by the analysis and assessment through uncertain compoents.The expanded uncertainty was U=0.8mg(k=2).The first cause for the uncertainty of measurement was the precision of peak areas of the sample solution of Dibydroartemisinin.