摘要
建立高效液相色谱法测定2,3,5,6-四氟苯酚中的有关物质。分析3批样品,结果显示:2,3,5,6-四氟苯酚与对羟基四氟苯甲酸、五氟苯甲酸的分离效果好。对羟基四氟苯甲酸的检测限和定量限分别为0.0312、 0.0625μg/mL,五氟苯甲酸的检测限和定量限分别为0.0797、 0.1992μg/mL。对羟基四氟苯甲酸和五氟苯甲酸的平均回收率分别为103.6%~107.5%、104.3%~107.9%。结果表明:对羟基四氟苯甲酸、五氟苯甲酸、最大未知单个杂质和总杂质的量均符合《中国药典》(2020版)规定。
High performance liquid chromatography(HPLC)was established for the determination of related substances in 2,3,5,6-tetrafluorophenol.After analyzing three batches of samples,results showed that the separation effect of 2,3,5,6-tetrafluorophenol and impurities(p-hydroxytetrafluorobenzoic acid and pentafluorobenzoic acid)was good.The detection limit and quantification limit of p-hydroxytetrafluorobenzoic acid were 0.0312μg/mL and 0.0625μg/mL respectively and those of pentafluorobenzoic acid were 0.0797μg/mL and 0.1992μg/mL respectively.The average recovery rate of p-hydroxytetrafluorobenzoic acid and that of pentafluorobenzoic acid ranged from 103.6%to 107.5%and from 104.3%to 107.9%respectively.The contents of p-hydroxytetrafluorobenzoic acid,pentafluorobenzoic acid,the maximum unknown single impurity,and total impurities all complied with the provisions of Pharmacopoeia of the People’s Republic of China(2020 edition).
作者
韦林洪
殷义平
张虞婷
WEI Lin-hong;YIN Yi-ping;ZHANG Yu-ting(Yangzhou Polytechnic College,Yangzhou 225009,China;Yangzhou Engineering Research Center of Agricultural Produce Intelligent Measurement and Control&Cleaner Production,Yangzhou 225009,China;Jiangsu Tianhe Pharmaceutical CO.,Ltd.,Yangzhou 225200,China)
出处
《扬州职业大学学报》
2024年第1期31-35,共5页
Journal of Yangzhou Polytechnic College
基金
江苏省科技计划现代农业重点项目(BE2022349)。
关键词
高效液相色谱法
2
3
5
6-四氟苯酚
对羟基四氟苯甲酸
五氟苯甲酸
high performance liquid chromatography
2,3,5,6-tetrafluorophenol
p-hydroxytetrafluorobenzoic acid
pentafluorobenzoic acid
