分子排阻色谱法测定注射用头孢呋辛钠舒巴坦钠中的高分子杂质___
Determination of high molecular mass impurities in cefuroxime sodium and sulbactam sodium for injection by molecular exclusion chromatography
分类号：
出版年·卷·期（页码）：2010,30 (1):0-0
DOI:
10.16155/j.0254-1793.2017.01.01
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Objective:To establish a method for the determination of high molecular mass impurities in cefuroxime sodium and sulbactam sodium for injection(3∶1).Methods:The analytical column was Superdex peptide 10/300 GL and the mobile phase was composed of phosphate buffer(pH 7.0,0.025 mol·L-1)-acetonitrile(70∶30) at a flow rate of 1 mL·min-1;The detection wavelength was set at 254 nm.The content of impurities was calculated against the content of cefuroxime.Results:High molecular mass impurities in cefuroxime was separated completely from cefuroxime;The linear range of cefuroxime was 50-100 μg;The repetitiveness was fine(RSD=0.88%,n=5).Conclusion:The method is simple,rapid and reliable.It is applicable for the quality control of cefuroxime sodium and sulbactam sodium for injection(3∶1).
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