重复性测定结果可接受性检查方法在高效液相法色谱法含量测定中的应用

Application of acceptable assessment method of the repeatability test results in high performance liquid chromatography for assay

目的:根据我国国家标准,建立药物含量测定高效液相色谱法重复性测定结果可接受性检查的一般流程。方法:设计了实验室内小型实验方案,通过统计学方法推导出重复性限。从而计算得到相应方法的可接受性限。结果:高效液相色谱法进行药物含量测定的重复性限为r=3.44。结论:通过实验室内部数据的采集,评估重复性限,建立药物含量测定高效液相色谱法重复性测定结果可接受性检查的方法,为完善《中国药典》中方法重复性的要求提供了依据。

Objective： To establish a general process of acceptable assessment method of the repeatability test results in high performance liquid chromatography for drug assay according to China National Standard. Methods： Based on an internal analytical lab experiment, a repeatable limit was calculated by statistical method, then an acceptable assessment method was proposed. Results： The value of the repeatable limit for determination of assay by high performance liquid chromatography was 3.44 approximately. Conclusion： A general acceptable assessment method of the repeatability test results in high performance liquid chromatography for assay is established. That provides the scientific support to improve the requirements on the repeatability in Chinese Pharmacopoeia.