摘要
目的:分析高效液相色谱法检查有关物质时容易被误认为是杂质的峰,并进一步研究其形成机制。方法:结合日常检验工作和相关文献,对易被误认为是杂质峰进行研究总结。结果:易被误认为是杂质峰的包括溶剂峰、有机酸盐峰、无机酸盐峰和辅料峰,对这些峰的形成原因进行分析。结论:分析工作者在药物的有关物质高效液相色谱法的方法开发和检查中,应对检验过程中出现的杂质峰予以重视,以免出现误判。
Objective:To analyze the peaks which are easily mistaken for impurity in related substances by high performance liquid chromatography(HPLC) and study their formation mechanisms.Methods:The peaks which are easily mistaken for impurity were summarized in combination with daily inspection work and related literature.Results:The peaks which are easily mistaken for impurity included peaks of solvent,peaks of organic acid salts,peaks of inorganic acid salts and peaks of ingredients.The possible reasons for the misjudged impurity peaks were analyzed.Conclusion:Analytical workers should pay attention to the impurity peaks appearing in the test process while developing and inspecting the related substances of drugs by using HPLC so as to avoid misjudgment.
作者
王丽
Wang Li(Wuxi Institute for Drug Control,Jiangsu Province,Wuxi 214028,China)
出处
《中国药事》
CAS
2019年第11期1254-1258,共5页
Chinese Pharmaceutical Affairs
基金
无锡市科技发展基金(编号WX18IVJN714)
