注射用美罗培南含量测定不确定度评定

Uncertainty of Determination of Meropenem for Injection

目的:评定高效液相色谱法测定注射用美罗培南含量的不确定度,对影响含量测定的影响因素进行分析评定。方法:建立数学模型分析影响不确定度评定的因素并评定不确定度。结果:高效液相色谱法测定注射用美罗培南的扩展不确定度为1.63%(k=2)。注射用美罗培南含量测定结果为98.65%±1.61%,第二项为U95之值。结论:对注射用美罗培南含量测定不确定度研究结果显示,对照品称量、供试品溶液精密量取体积和对照品峰面积重复性测量是此次不确定度评定的主要来源。

Objective:To evaluate the uncertainty of the determination of meropenem for injection by high performance liquid chromatography(HPLC),and to analyze and evaluate the influencing factors.Methods:A mathematical model was established to analyze the factors affecting the uncertainty evaluation and evaluate the uncertainty.Results:The expanded uncertainty of meropenem for injection was 1.63%(k=2).The content of meropenem for injection was 98.65%±1.61%,and the second item in brackets was the value of U 95.Conclusion:The results of the uncertainty study on the determination of meropenem for injection showed that the main sources of the uncertainty evaluation were the weighing of the reference substance,the precise volume of the test solution and the repeatability of the peak area of the reference substance.