文章摘要
李樾,梁婷婷,孙会敏.HPLC法测定注射用冷冻干燥用卤化丁基橡胶塞中抗氧剂1010及硫化剂在药液中的迁移[J].中国药事,2019,33(3):283-289
HPLC法测定注射用冷冻干燥用卤化丁基橡胶塞中抗氧剂1010及硫化剂在药液中的迁移
Determination of Antioxidant 1010 and Curing Agent in Halogenated Butyl Rubber Plug for Freeze Drying Injection and Their Migration in Medicines by High Performance Liquid Chromatography
投稿时间：2018-05-19  
DOI：10.16153/j.1002-7777.2019.03.008
中文关键词: 高效液相色谱法  抗氧剂  硫化剂
英文关键词: HPLC  antioxidant  curing agent
基金项目:中国食品药品检定研究院中青年课题（编号2016C2）
作者单位E-mail
李樾 中国食品药品检定研究院, 北京 100050  
梁婷婷 中国食品药品检定研究院, 北京 100050  
孙会敏 中国食品药品检定研究院, 北京 100050 sunhm@nifdc.org.cn 
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中文摘要:
      目的：建立HPLC方法，考察药用卤化丁基橡胶塞中的抗氧剂、硫化剂及其在药液中的迁移情况。方法：采用Sunfire-C18（4.6 mm×150 mm，5 μm）色谱柱；流动相：乙腈-四氢呋喃-水（6：3：1）；流速：1.5 mL·min-1；检测波长：280 nm；柱温：35℃；进样量：20 μL。结果：抗氧剂1010及硫化剂硫磺在浓度0.004~0.5 mg·mL-1具有良好的线性关系（r ≥ 0.9996）。抗氧化剂1010及硫化剂硫磺提取试验回收率范围分别是102.05%~111.55%及91.75%~94.83%；抗氧化剂1010及硫化剂硫磺迁移试验回收率范围分别为98.92%~110.70%及98.68%~106.63%；各回收率试验RSD均不大于5%（n=9）。结论：本方法灵敏、准确、可靠，可用于药用卤化丁基橡胶塞中抗氧剂及硫化剂的提取及迁移研究。
英文摘要:
      Objective:To establish a HPLC method for determination of antioxidants and curing agents in halogenated butyl rubber plug and their migration in medicine. Methods:A Sunfire-C18 column (4.6 mm×150 mm, 5 μm) was used with acetonitrile-tetrahydrofuran-water (6:3:1) as mobile phase. The flow rate was 1.5 mL·min-1 and the detection wavelength was 280 nm. The chromatography was conducted at 35℃ and 20 μL were injected. Results:Antioxidant 1010 and curing agent sulfur had a good linear relationship (r ≥ 0.9996) in the range of 0.004-0.5 mg·mL-1. The recovery range of antioxidant 1010 extraction test was 102.05%-111.55%, the recovery range of curing agent sulfur extraction test was 91.75%-94.83%, the recovery range of antioxidant 1010 migration test was 98.92%-110.70%, and the recovery range of curing agent sulfur migration test was 98.68%-106.63%. The RSD of each recovery test was no more than 5% (n=9). Conclusion:The method is sensitive, accurate and reliable, which is suitable for the extraction and migration studies of antioxidants and curing agents in halogenated butyl rubber plug for medicines.
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