维C银翘片中马来酸氯苯那敏的HPLC法测定结果的不确定度评价

Evaluation of Uncertainty in Determination of Chlorpheniramine in Vitamin C YinQiao Tablets by HPLC

目的对HPLC法测定维C银翘片中马来酸氯苯那敏含量的不确定度分析,找出影响不确定的因素。方法根据含量测定不确定度的数学模型,对各个不确定度分量进行计算。结果本次检测扩展不确定度为2.0%,k=2。结论根据测量结果及考虑不确定度影响后,可以判定样品的检验结论为不合格。我们在药品检验过程中经常会需要运用不确定度评定来判断检验工作的准确性,本文根据药品检验标准对维C银翘片中马来酸氯苯那敏含量进行测量不确定度评定。

OBJECTIVE To analyze the uncertainty of determination of chlorpheniramine in vitamin C YinQiao tablets by HPLC and find out the factors affecting the uncertainty.METHODS According to the mathematical model of uncertainty in content determination,each uncertainty component was calculated.RESULTS The extended uncertainty was 2.0%,K=2.CONCLUSION According to the result of measurement and considering the influence of uncertainty,the sample can be judged to be unqualified.In the process of drug testing,we often need to use the evaluation of uncertainty to judge the accuracy of testing work.In this paper,the uncertainty of measurement for the content of chlorpheniramine in vitamin C YinQiao tablets was evaluated according to the drug inspection standard.