HPLC法测定葡萄糖输液袋(瓶)中增塑剂溶出量  

Determination of Plasticizer Released from Infusion Containers of Glucose by HPLC

作　　者：杨松[1] 李阳[1] 邓晓梅 张鹏[1] 赵文军[1] 

机构地区：[1]沈阳军区联勤部药品仪器检验所,沈阳110026 [2]沈阳市辉山社区卫生服务中心

出　　处：《中国药师》2013年第11期1706-1707,共2页China Pharmacist

摘　　要：目的:建立HPLC法测定葡萄糖输液袋(瓶)中增塑剂邻苯二甲酸二-(2-乙基已基)酯(DEHP)溶出量。方法:采用Inertsil ODS-sp(250 mm×4.6 mm,5μm)色谱柱;流动相:100%甲醇;流速:1.0 ml·min^(-1);检测波长:230 nm;柱温:30℃;进样量:20μl。结果:DEHP在0.56~9.05μg·ml^(-1)范围内线性关系良好(r=0.999 2),回收率为99.3%(RSD=1.2%,n=9)。结论:该方法专属性强,灵敏度高,重复性好,适用于静脉输液袋(瓶)的质量控制。Objective： To establish an HPLC method for the quantitative determination of DEHP released from infusion containers of glucose. Method： An Inertsil ODS-sp（250 mm x 4.6 mm,5 Ixm） column was used, and the mobile phase was 100% methanol. The detection wavelength was at 230nm, the flow rate was 1.0 ml ~ min - ：, the column temperature was 30~C and the sample size was 20 ~1. Result： The standard curve of DEHP was linear within the range of 0.56-9.05 I^g ~ ml - ： （ r = 0.999 2 ）. The average recovery was 99.3% （RSD = 1.2% ,n =9）. Conclusion： The method is sensitive, specific and reproducible, and suitable for the analysis of DEHP released from infusion containers of glucose.

关 键 词：静脉输液袋(瓶) 邻苯二甲酸二-(2-乙基已基)酯 高效液相色谱法 

分 类 号：R927.11[医药卫生—药学]