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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 a HPLC method for the determination of the amount of di-2-ethylhexyl phthalate (DEHP) which is a plasticizer in glucose infusion bags. Methods: The column of Inertsil ODS-sp (250 mm × 4.6 mm, 5 μm) was used. The mobile phase consisted of 100% methanol. The flow rate was 1.0 ml · min -1. The detection wavelength was 230 nm. Injection volume: 20μl. Results: The linear range of DEHP was 0.56-9.05 μg · ml -1 (r = 0.999 2). The recovery was 99.3% (RSD = 1.2%, n = 9). Conclusion: The method is highly specific, sensitive and reproducible. It is suitable for the quality control of IV bags.