医药导报2024，Vol.43Issue(5)：712-716,5.DOI:10.3870/j.issn.1004-0781.2024.05.007
药用橡胶塞中可提取硫和4-叔辛基苯酚及2-巯基苯并噻唑的检测
Simultaneous Determination of Extractable Sulfur,4-Octylphenol and 2-Nercaptobenzo-thiazole in Pharmaceutical Halogenated Butyl Rubber Stopper
摘要
Abstract
Objective To establish a method for simultaneous determination of extractable sulfur,4-octylphenol and 2-nercaptobenzothiazole(2-MBT)in pharmaceutical halogenated butyl rubber stopper by HPLC.Methods The mixed solution of toluene and methanol was adopted as the extraction solvent,and a HPLC method for detection of extractable sulfur,4-octylphe-nol and 2-MBT was developed.The detection was performed on Agilent ZORBAX SB-C18 column with mobile phase consisted of acetonitrile-water(85∶15)at the flow rate of 1.0 mL·min-1.The column temperature was 40℃,and detection wavelength was set at 280 nm.The injection sample volume was 20 μL.Results The linear ranges of sulfur,4-octylphenol and 2-MBT were 0.20-501.00 μg·mL-1(r=0.999 8),0.20-502.95 μg·mL-1(r=0.999 9),0.22-547.53 μg·mL-1(r=0.999 8),respectively.The limits of quantitation were 0.40 μg·mL-1,0.25 μg·mL-1 and 0.15 μg·mL-1,relative standard deviations(RSDs)of pre-cision,stability and reproducibility tests were all lower than 3%.The extraction recoveries were 93.5%-104.8%,99.0%-100.6%and 103.0%-107.7%,respectively.The migration recoveries were 97.0%-101.8%,98.7%-110.3%and 89.3%-94.0%,respec-tively.Conclusion The method is sensitive,rapid,convenient and reproducible,and can be used for simultaneous determina-tion of extractable sulfur,4-octylphenol and 2-MBT in pharmaceutical halogenated butyl rubber stopper.关键词
药用卤化丁基橡胶塞/可提取硫/4-叔辛基苯酚/2-巯基苯并噻唑/含量测定Key words
Pharmaceutical halogenated butyl rubber stopper/Extractable sulfur/4-Octylphenol/2-Nercaptobenzothia-zole/Content determination分类
医药卫生引用本文复制引用
程佳美,贾菲菲,李颖,赵霞,杨会英..药用橡胶塞中可提取硫和4-叔辛基苯酚及2-巯基苯并噻唑的检测[J].医药导报,2024,43(5):712-716,5.基金项目
中国食品药品检定研究院中青年发展研究基金资助项目(2023C10). （2023C10）
