液相色谱测定药用聚丙烯组合盖中抗氧剂1010的不确定度评定  

The Evaluation of Uncertainty for the Content of Antioxidant 1010 in Determining the Medical Polypropylene Combined Cover by Liquid Chromatography

作　　者：曲亚南 方旻[1] 吕鹏举[1] 谢新艺[1] 

机构地区：[1]广东省医疗器械质量监督检验所包装材料容器检验中心,广州510663

出　　处：《中国医疗器械信息》2013年第4期48-52,共5页China Medical Device Information

摘　　要：本文按欧洲药典3.1.3聚烯烃项下检测抗氧剂1010的方法,对药用聚丙烯组合盖样品进行平行检测,并建立数学模型,以探寻不确定度的主要影响因素,系统分析和量化不确定度各分量。结果表明采用液相色谱测定聚丙烯组合盖中抗氧剂1010的不确定度,主要由回收率和标准溶液浓度的不确定度而引起。The antioxidant 1010 in the Medicinal Polypropylene Combined Cover samples was tested in parallel by Liquid Chromatography according to the method of the European Pharmacopoeia 3.1.3 polyolefin and a mathematical model was established to explore the main factors of uncertainty during the test. The results showed that the major factors came from the uncertainty of recovery rate and concentration of standard solution.

关 键 词：液相色谱法 药用聚丙烯 抗氧剂1010 不确定度 

分 类 号：R197.39[医药卫生—卫生事业管理]