HPLC法测定阿莫西林含量的不确定度评价

Evaluation of Uncertainty in Determination of Amoxicillin by HPLC

目的对高效液相色谱(HPLC)法测定阿莫西林含量的结果进行不确定度评价,分析各种误差来源,以保证结果数据准确。方法建立数学模型,分析不确定度分量,计算合成不确定度并确定测量结果在95%置信区间(95%CI)下的扩展不确定度(Extended Uncertainty),评估检验结果的可信度。结果计算出扩展不确定度U=0.40%(k=2),根据评定结果,供试品中阿莫西林含量可表示为X=(84.23±0.40)%。结论天平称量是结果产生不确定度的最主要因素。

OBJECTIVE To analyze the uncertainty of determination of amoxicillin by high performance liquid chromatography（ HPLC）,find out the effect factors in order to ensure the accuracy of the data. METHODS A mathematical model was established for analyzing of uncertainty components,determining the expanded uncertainty of the measurement results under the 95% confidence interval（ 95% CI）. RESULTS Extended uncertainty U = 0. 40%（ k = 2）. The content of amoxicillin was X =（ 84. 23 ± 0. 40） %.CONCLUSION The uncertainty of scale-weigh is the most important factor.