高效液相色谱法测定右旋糖酐40原料及其氯化钠注射液中糠醛含量
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卫生部2009年度卫生公益性行业科研专项(200902008).


High-performance liquid chromatography in determining furfural in dextran 40 raw material and its sodium chloride injection
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Supported by 2009 Special Fund for Scientific Research for Public Interest of the Ministry of Health (200902008).

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    摘要:

    目的 建立高效液相色谱法测定右旋糖酐40原料及其氯化钠注射液中糠醛的含量。方法 色谱柱: MACHEREY-NAGEL C18(250 mm×4.6 mm, 5 μm); 流动相: 甲醇-水(磷酸调节pH值为3.0,体积比为1090); 柱温: (35±5)℃; 流速: 1.0 mL/min; 检测波长: 275 nm。结果 糠醛在0.01~10.10 μg/mL质量浓度范围内与峰面积呈良好的线性关系,线性方程为Y=192 440.8X-3 711.6(R=0.999 9),日间精密度RSD为0.5%;平均回收率为98.1%(RSD为0.3%),最低检测限为0.003 μg/mL。右旋糖酐40原料中糠醛含量为0.071 10~1.306 0 μg/g,右旋糖酐40氯化钠注射液中糠醛的含量为0.018 0~0.198 8 μg/mL。结论 该法简便、准确,适用于右旋糖酐40原料及其氯化钠注射液中糠醛的含量测定。

    Abstract:

    Objective To establish a high-performance liquid chromatography (HPLC) method for determining furfural in dextran 40 raw material and its sodium chloride injection. Methods The chromatographic conditions adopted were as follows: a MACHEREY-NAGEL C18 (4.6 mm×250 mm, 5 μm), a mobile phase of methanol-water (pH=3.0, VV=1090), the column temperature at (35±5)℃, the flow rate at 1.0 mL/min, and the detection wavelength at 275 nm. Results The calibration curve was linear within the concentration range of 0.01-10.10 μg/mL, with the regression equation being Y=192 440.8X-3 711.6 (R=0.999 9), and the inter-day RSD was 0.5%; the average recovery rate was 98.1% (RSD being 0.3%), with the limit of detection (LOD) being 0.003 μg/mL. The level of furfural was 0.071 10-1.306 0 μg/g in dextran 40 raw material and 0.018 0-0.198 8 μg/mL in the dextran 40 sodium chloride injection. Conclusion The method of this study is simple and accurate, and can be used for determining the levels of furfural in dextran 40 raw material and its sodium chloride injection.

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  • 收稿日期:2013-06-07
  • 最后修改日期:2013-07-30
  • 录用日期:2013-10-22
  • 在线发布日期: 2013-12-23
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