目的:研究并建立HPLC-CAD 法测定壬苯醇醚及壬苯醇醚栓中游离聚乙二醇（PEG）的含量。方法:采用HALO ES-C18 色谱柱（4.6 mm×250 mm, 5 μm）, 流动相为甲醇- 水（80∶20）, 流速1.0 mL·min-1, 柱温35 ℃, 进样量20 μL, 检测器为CAD, 雾化气体为氮气, 蒸发管温度50 ℃, 气流压力约6.895 kPa。结果:PEG 400 的检测下限为0.006 μg, 定量下限0.01 μg, 线性范围为1.05~5.25 μg·mL-1（r=0.999 7）, 壬苯醇醚、壬苯醇醚栓的平均回收率（n=3）分别为99.3%~101.6%（RSD=0.10%~0.30%）和103.1%~104.9%（RSD=0.10%~0.20%）。结论:该方法简单、快速、灵敏、准确, 适合对壬苯醇醚及壬苯醇醚栓中游离PEG 进行质量控制。
Objective：To study and establish an HPLC-ELSD (electrospray detector) method for the determination of free PEG in nonoxinol and nonoxinol suppositories. Methods：Free PEG was determined by HPLC-CAD with an HALO ES-C18 column (4.6 mm×250 mm, 5 μm), the mobile phase was methanol-water (80∶20) at the flow rate of 1.0 mL·min-1, the column temperature was 35 ℃ and the injection volume was 20 μL, CAD was used as detector, the evaporate tube temperature was 50 ℃, the nebulizer gas was nitrogen and the flow pressure was around 6.895 kPa. Results：The lower limit of detection for PEG 400 was 0.006 μg, the lower limit of quantification was 0.01 μg, and the linear range was 1.05-5.25 μg·mL-1 (r=0.999 7). The mean recovery (n=3) of nonoxinol and nonoxinol suppositories were 99.3%-101.6% (RSD=0.10%-0.30%) and 103.1%-104.9% (RSD=0.10%-0.20%). Conclusion：This method is simple, fast, sensitive, accurate and suitable for the quality control of free PEG in nonoxinol and nonoxinol suppositories.
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