HPLC法测定酒石酸美托洛尔片含量的测量不确定度评定

Evaluation of Measurement Uncertainty for the Content of Metoprolol Tartrate Tablets by HPLC

目的评定HPLC法测定酒石酸美托洛尔片含量的测量不确定度。方法通过建立数学模型,分析、量化各测量不确定度分量,并最终合成标准测量不确定度,给出扩展测量不确定度报告。结果HPLC法测定酒石酸美托洛尔片含量的扩展不确定度为1.1%,测量结果表示为(98.2±1.1)%,k=2。结论HPLC法测定酒石酸美托洛尔片含量的不确定度评定科学、完整,可为HPLC法测定其他药物制剂的含量方法提供参考依据。

OBJECTIVE To evaluate the measurement in the assay of Metoprolol tartrate tablets with HPLC.METHODS Analyzing and quantifying the components of each measurement uncertainty by establishing mathematical models,and the standard measurement uncertainty was synthesized,and the extended measurement uncertainty was given.RESULTS The expanded uncertainty was 1.1%,and should be expressed as(98.2±1.1)%,k=2.CONCLUSION The evaluation of uncertainty in the determination of Metopro Tartrate Tables by HPLC is scientific and complete,which can provide reference for the determination of other pharmaceutical preparations by HPLC.