品牌与标准化Issue(4)：13-15,3.DOI:10.3969/j.issn.1674-4977.2024.04.005
离子色谱法测定肝素钠总己糖胺中半乳糖胺含量的方法研究
Determination of Galactosamine in Total Hexosamine of Heparin Sodium by Ion Chromatography
米文强 1任风芝 1刘建芬 2张向彬 2王彩肖 2李乐乐2
作者信息
- 1. 华北制药集团新药研究开发有限责任公司,河北石家庄 052165||河北省多组分生化药物制备技术创新中心,河北石家庄 050000
- 2. 华北制药华坤河北生物技术有限公司,河北石家庄 050000||河北省多组分生化药物制备技术创新中心,河北石家庄 050000
- 折叠
摘要
Abstract
Objective:To establish a method for the determination of galactosamine content in heparin sodium total hexosamine.Methods:The standard and test samples are hydrolyzed at 100 ℃ for 6 hours,and then analyzed by Dionex ICS5000 ion chromatograph,using 14 mm sodium hydroxide solution as eluent at a flow rate of 0.5 mL/min,passing through Dionex amino acid trap column(50 mm×4 mm)and PA20 column(150 mm ×3 mm),and entering the amperometric detector equipped with Au working electrode and pH-Ag-AgCl reference electrode.Results:After hydrolysis for no less than 6 hours,the test samples are fully hydrolyzed,and there is no interference peak in the blank solution.In the chromatogram of the hydrolyzed standard solution,the theoretical plate number,separation degree,tailing factor,etc.all met the requirements of USP<831>.The detection limit and quantitation limit of galactosamine were 2 ng/mL and 4 ng/mL,respectively.Galactosamine had good linearity in the concentration range of 4～160 ng/mL,the average recovery rate was 101.2％,and the RSD was 2.64％.The RSD of the test results of the hydrolyzed standard solution and the hydrolyzed test sample solution placed for 24 hours is 1.53％.Conclusion:The method has good specificity,system suitability,linearity,sensitivity,and recovery rate,and is suitable for the determination of galactosamine content in heparin sodium total hexosamine.关键词
肝素钠/离子色谱/半乳糖胺Key words
heparin/HPIC/galactosamine引用本文复制引用
米文强,任风芝,刘建芬,张向彬,王彩肖,李乐乐..离子色谱法测定肝素钠总己糖胺中半乳糖胺含量的方法研究[J].品牌与标准化,2024,(4):13-15,3.
