高效液相色谱法测定药物涂层球囊中紫杉醇含量的不确定度评定

Evaluation of uncertainty for determination of paclitaxel content in drug-eluting balloons by high performance liquid chromatography

采用高效液相色谱法测定药物涂层球囊中紫杉醇的含量,并评定测量不确定度。建立了测量不确定度评定模型,测量过程中的不确定度来源主要有标准溶液配制、样品处理、标准曲线拟合、测量重复性。比较结果表明,高效液相色谱法测定药物涂层球囊中紫杉醇含量的测量不确定度主要来自测量重复性和标准工作溶液的配制两个方面。药物涂层球囊中紫杉醇含量的合成标准不确定度为0.104 mg,扩展不确定度为0.21 mg,测量结果可表示为(11.54±0.21)mg(k=2)。

The content of paclitaxel in drug-eluting balloons(DEB)was determined by high performance liquid chromatography(HPLC).The model of uncertainty evaluation for this process was established and the sources of uncertainty were assessed as standard solution preparation,sample treatment,standard curve and measurement repeatability.The uncertainty of paclitaxel content in drug-eluting balloons mainly resulted from the repeatability of determination and the preparation of standard solutions with the comparison among the components of uncertainty.The synthetic standard uncertainty of paclitaxel content in drug-eluting balloons was 0.104 mg,and the expanded uncertainty was 0.21 mg.The result of measurement was(11.54±0.21)mg(k=2).