顶空毛细管气相色谱法测定阿维巴坦钠中三甲胺、三乙胺  

Determination of Residual Trimethylamine and Triethylamine in Avibactam Sodium by Headspace Gas Chromatography

作　　者：孙玉双 贾全 表亚囡 巩海雪 鲍楠楠 Sun Yushuang;Jia Quan;Biao yanan;Gong Haixue;Bao Nannan(NCPC Hebei Huamin Pharma Co.,Ltd,Shijiazhuang 052165)

机构地区：[1]华北制药河北华民药业有限责任公司,石家庄052165

出　　处：《化工与医药工程》2021年第3期31-34,共4页Chemical and Pharmaceutical Engineering

摘　　要：阿维巴坦钠原料药制备过程中使用到三甲胺、三乙胺这两种有机溶剂,在工艺过程中可能无法完全去除,为保证产品质量,建立了阿维巴坦钠原料药中三甲胺、三乙胺两种残留溶剂含量的测定方法。采用顶空气相色谱法,FID检测器,Agilent CP-Volamine毛细管柱(30 m×0.32 mm,0.5μm),载气为氮气,流速2.0 mL/min,程序升温。经验证,本方法操作简便,灵敏度高,可用于准确测定阿维巴坦钠原料药中三甲胺、三乙胺的含量。Two organic solvents,trimethylamine and triethylamine,were used in the preparation of Avibactam sodium API,which can not be completely removed in the process.In order to ensure product quality,a method to determine the content of trimethylamine and trithylamine residual solvent in Avibactam sodium was established in this paper.Headspace gas chromatography was used:FID,Agilent CP-Volamine capillary column(30 m×0.32 mm,0.5μm),nitrogen as carrier gas,flow rate of 2.0 mL/min,temperature programmed.It was proved that the method was simple and high sensitivity,and can be used for accurate determination of trimethylamine and triethylamine content in Avibactam Sodium API.

关 键 词：气相色谱法 顶空进样 阿维巴坦钠 三甲胺 三乙胺 

分 类 号：TQ460.7[化学工程—制药化工]