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| 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 |
| 张珍1,王嫦鹤2,吴沛佳2,郭欢迎2,刘海静1,2*,丁丽霞3,杜冠华4* |
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(1. 陕西中医学院,咸阳 712046
2. 陕西省食品药品检验所,西安 710061
3. 中国药学会,北京 100022
4. 中国医学科学院北京协和医学院药物研究所,北京市药物靶点研究与新药筛选重点实验室,北京 100050
*通信作者) |
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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1090); 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。 |
| 关键词: 右旋糖酐原料 右旋糖酐40氯化钠注射液 糠醛 高效液相色谱法 |
| DOI： |
| 投稿时间：2013-06-07修订日期：2013-07-30 |
| 基金项目:卫生部2009年度卫生公益性行业科研专项(200902008). |
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| High-performance liquid chromatography in determining furfural in dextran 40 raw material and its sodium chloride injection |
| ZHANG Zhen1,WANG Chang-he2,WU Pei-jia2,GUO Huan-ying2,LIU Hai-jing1,2*,DING Li-xia3,DU Guan-hua4* |
(1. Shaanxi University of Chinese Medicine, Xianyang 712046, Shaanxi, China
2. Shaanxi Institute for Food and Drug Control, Xi’an 710061, Shaanxi, China
3. Chinese Pharmaceutical Association, Beijing 100022, China
4. Institute of Materia Medica, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing Key Laboratory of Drug Targets Identification and Drug Screening, Beijing 100050, China
*Corresponding author. ) |
| 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=1090), 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. |
| Key words: dextran 40 raw material dextran 40 sodium chloride injection 2-furaldehyde high-performance liquid chromatography |
