三层共挤膜输液袋中抗氧剂168降解产物DBP的提取和测定.pdfVIP

中国医药工业杂志 Chinese Journal of Pharmaceuticals 2014 , 4S (7) • 677 • 三层共挤膜输液袋中抗氢剂 168 降解产物DBP 的提取和测定 林黄静，吴莹，张毅兰* (中国医药工业研究总院上海医药工业研究院，国家食品药品监督管理局药品包装材料科研检验中心，上海201203) 摘要:建立了高效液相色谱法测定三层共挤膜输液袋中抗氧剂 168 降解产物 2， 4- 二叔丁基苯盼 (DBP) 在不同提取介质中 的含量，研究 DBP 向不同介质的迁移情况。采用 Agilent C8 色谱柱，流动相为乙睛:水:四氢吠喃 (45 : 35 : 20) ，检 测波长 280 nmo DBP 在 1 ~ 50μg1ml 范围内线性关系良好，在 pH 3.0 和 pH 9.0 溶液以及 20% 乙醇介质中的回收率均介 于 90%~ 105% , RSD 小于 3% 。 关键词:三层共挤膜输液袋:抗氧剂 168: 2，4- 二叔丁基苯盼:高效液相色谱:测定 中图分类号: 0657.r2 文献标志码:A 文章编号: 1001-8255 (2014) 07-0677-04 Extraction and Determination ofDBP Degradated 企om Irgafos 168 in Three-layer Co-extrusion Film for Infusion Bag LIN Huangjir毡， WUYir毡， ZHANG Yilan* (SFDA Research and Inspection Center 01Pharmaceutical Packaging Materials , Shanghai Institute 01Pharmaceuticallndust，η， China State Institute 01Pharmaceuticallndus町. Shanghai 201203) ABSTRACT: An HPLC method was established for the determination of 2 ,4-di-tert-butyl-phenol (DBP) in different extractants, which was the degradation product of Irgafos 168 仕om three-Iayer co-extrusion film for infusion bag. The migration of DBP to the extractants was also studied. An Agilent CI8 colurnn was used with the mobile phase of acetonitrile : water : tetrahydrofuran (45 : 35 : 20) at the detection wavelength of 280 nm. It was linear in the concentration range of 1 - 50μg/ml. The average recoveries were between 90 % - 105% with RSDs less than 3 % in pH 3.0 solution, pH 9.0 solution and 20% ethanol, respectively. Key Words: three-Iayer co-extrusion film for infusion bag; Irgafos 168; 2 ,4-di-tert-butyl-phenol (DBP); HPLC; dete口nination 混合，外层为机械强度较高的聚酶或聚丙烯材料 [1] 。