文章摘要
张朝阳,汤清娟,许凯,晏建磊,杨锐,汤龙,孙会敏.柱前衍生化HPLC 法测定聚乙二醇400中的甲醛*[J].中国药品标准,2017,18(6):465-468
柱前衍生化HPLC 法测定聚乙二醇400中的甲醛*
Determination of Formaldehyde in Polyethylene Glycol 400 by HPLC with pre-column derivatization*
投稿时间:2017-08-30  修订日期:2017-12-06
DOI:
中文关键词: 聚乙二醇400  甲醛  甲醛-DNPH  HPLC法
英文关键词: formaldehyde  polyethylene glycol 400  formaldehyde-DNPH  HPLC
基金项目:十三五国家新药创制-化药制剂质量评价关键技术研究
作者单位E-mail
张朝阳 中国食品药品检定研究院 zhaoyang_zhang2012@126.com 
汤清娟 运城学院  
许凯 中国食品药品检定研究院  
晏建磊 中国食品药品检定研究院  
杨锐 中国食品药品检定研究院  
汤龙 中国食品药品检定研究院  
孙会敏 中国食品药品检定研究院  
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中文摘要:
      建立柱前衍生化后HPLC测定聚乙二醇400(PEG400)中甲醛含量的方法。方法: PEG400中加入2,4-DNPH衍生化试剂,在25℃下反应30min,使用CAPCELL PAK DD-C8 柱(4.6mmm×150mm, 5μm)分离,流动相为水-乙腈,梯度洗脱,流速为1.0mL?min-1,检测波长360nm,柱温为30℃。结果:聚乙二醇400中的残留甲醛经衍生化后可实现较好分离测定,甲醛的衍生化效率为90.8%,甲醛-DNPH浓度在0.1~60μg?mL-1范围内有良好的线性关系(r=1),方法平均回收率为90.34%。结论:本方法准确,可靠,重现性好,可作为聚乙二醇400中残留甲醛的质控方法。
英文摘要:
      To establish an HPLC method for the quantitative determination of formaldehyde in polyethylene glycol 400 (PEG400) with pre-column derivatization. Methods: The derivatization reaction of formaldehyde was carried out at 25℃ for 30min with 2,4-DNPH. The samples were separated on CAPCELL PAK DD-C8 column (4.6mm×150mm, 5μm) by the gradient elution of acetonitrile-water at a flow rate of 1.0ml/min. The detection wavelength was set as 360nm, and the column temperature was set as 30℃. Results: The formaldehyde in PEG400 could be separated and determined by pre-column derivatization. The derivatization efficiency of formaldehyde was 90.8%. There was good linearity in the range of 0.1~60 μg?mL-1 of formaldehyde-DNPH with r=1 and the average recovery as 90.34%. Conclusion: The method is accurate and reliable, and has the good reproducibility.It can be applied to the control of formaldehyde in PEG400.
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