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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
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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,5μm)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:20μL。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。 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.
作者 李樾 梁婷婷 孙会敏 Li Yue;Liang Tingting;Sun Huimin(National Institutes for Food and Drug Control,Beijing 100050,China)
出处 《中国药事》 CAS 2019年第3期283-289,共7页 Chinese Pharmaceutical Affairs
基金 中国食品药品检定研究院中青年课题(编号2016C2)。
关键词 高效液相色谱法 抗氧剂 硫化剂 HPLC antioxidant curing agent
作者简介 李樾,主管药师;研究方向:药品与包装材料的相容性;通信作者:孙会敏,研究员;研究方向:药用辅料及药品包装材料质量控制及安全性评价;Tel:(010)67095721;E-mail:sunhm@nifdc.org.cn.
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