中国医药科学2016，Vol.6Issue(9)：40-44,5.
劳拉西泮片有关物质检查方法的比较
The related substances test method comparison of lorazepam tablets
袁猛 1余振喜 2王慧文 1王菲菲1
作者信息
- 1. 安徽省蚌埠市食品药品检验中心，安徽蚌埠 233000
- 2. 中国食品药品检定研究院，北京 100050
- 折叠
摘要
Abstract
Objective To compare and discuss the differences and similarities of related substances test method on lorazepam tablets between Chinese pharmacopoeia 2015 edition two and United States pharmacopoeia 39 edition. MethodsThe differences in the aspects of impurity separation capability, methodology and the consistency of test results etc between the two test methods were compared and evaluated.ResultsThe separation effect of major impurities in lorazepam tablets by the test method of Chinese pharmacopoeia was bad, which could influence the determination of related substances result, while the impurity separation effect by the test method of United States pharmacopoeia was good, had high sensitivity and improved the specificity of analytical method and the accuracy of results.Conclusion The relative substances' test method of United States pharmacopoeia was more suitable for the impurity control in lorazepam tablets, which ensured the quality and safety of the product.关键词
劳拉西泮片/高效液相色谱法/有关物质/检测方法/分离度Key words
Lorazepam tablets/High performance liquid chromatography method/Related substances/Test method/Separating degree分类
医药卫生引用本文复制引用
袁猛,余振喜,王慧文,王菲菲..劳拉西泮片有关物质检查方法的比较[J].中国医药科学,2016,6(9):40-44,5.
