气相色谱法检测头孢呋辛钠原料药中2-乙基己酸残留量  

Determination of 2-ethylhexandic acid Acid Residue Solvent in Cefuroxime Sodium Raw Material by Gas Chromatography

作　　者：惠建军 雍志林 王策 师宝峰 彭燕 林妮妮 董颖 HUI Jian-jun;YONG Zhi-lin;WANG Ce;SHI Bao-feng;PENG Yan;LIN Ni-ni;DONG Ying(Beijing Leadingpharm Medical Technology Development Co.,Ltd.,Beijing 100094 China)

机构地区：[1]北京新领先医药科技发展有限公司,北京100094

出　　处：《北方药学》2021年第7期1-3,共3页Journal of North Pharmacy

摘　　要：目的:建立一种测定原料药头孢呋辛钠中2-乙基己酸有机溶剂残留量的气相色谱法。方法:改良药典通则中的前处理方法,以3-环己基丙酸作为内标,选择强极性色谱柱(聚乙二醇毛细管柱),FID检测器,程序升温法控制。结果:2-乙基己酸在0.00152~3.0458mg/mL范围内线性良好,相关系数r达到0.9998;低、中、高三个浓度的加样回收率介于89.36%~100.81%之间,相对标准偏差(RSD)值为4.55%。限度浓度溶液连续进样六次,RSD值为3.01%。结论:该方法系统适用性良好、灵敏度高、准确度、重复性良好,适用于头孢呋辛钠原料药中2-乙基己酸含量检查。Objective:To establish a method for determination the content of 2-ethylhexandic acid residue solvent in cefuroxime sodium raw material by gas chromatography.Methods:Used 3-cyclohexanepropionic acid as the internal standard,and adopted the strong polar column separate each component on a polyethylene glycol capillary column and equipped with FID detector under controlling oven programme.Results:2-ethylhexandic acid was linear over the concentration range of 0.00152~3.0458mg/mL with correlation coefficient(r)as 0.9998.The spiked recoveries were 89.36%to 100.81%at three concentration levels(low,medium and high)with the relative standard deviation(RSD)was 4.55%.When the limit concentration sample was tested six times continuously,the relative standard deviation(RSD)was 3.01%.Conclusion:The method was accurate,sensitive,precise,repetitive.It was a suitable approach for determination the content of 2-ethylhexandic acid in cefuroxime sodium.

关 键 词：头孢呋辛钠 气相色谱法 2-乙基己酸 

分 类 号：R917[医药卫生—药物分析学]