头孢地嗪钠中2-乙基己酸的残留检测  

Determination of 2-ethlhexanoic Acid Residue Solvent in Cefodizime Sodium Raw Material

作　　者：陈霞 胡泽锴 CHEN Xia;HU Ze-kai(Chengdu food and drug inspection and research institute,Chengdu 610000,China)

机构地区：[1]四川省成都市食品药品检验研究院,成都610000

出　　处：《海峡药学》2019年第2期82-84,共3页Strait Pharmaceutical Journal

摘　　要：目的建立气相色谙法测定原料药头孢地嗪钠中2-乙基己酸有机溶剂的残留量。方法以3-环己丙酸作为内标物,在聚乙二醇毛细柱上进行组分分离,分离效果良好。检测器温度:300℃;进样口温度:200℃;结果 2-乙基己酸浓度在0.07737～3.0948mg·mL^(-1)范围内,浓度与峰面积比值线性关系良好,回归方程y=0.9594x-0.0008,r=0.9999;高,中,低浓度平均回收率分别为96.87%、97.93%、95.90%;RSD=0.16%(n=9);结论该方法专属性强,准确可靠,重复性好,灵敏度高,适用于头孢地嗪钠中2-乙基己酸的残留检查。OBJECTIVE To establish a method for the determination of 2-ethlhexanoic acid residue solvent in cefodizime sodium raw material by the method of gas chromatography. METHODS Choose 3-Cyclohexanepropionic acid as the internal standard,and separate each component on a Polyethylene glycol capillary column.The effect was well;The FID temperature was set at 300℃,with injector at 200℃;RESULTS For 2-ethlhexanoic,calibration curve was linear in the range from 0.07737 to 3.0948μg·L ^-1 (r=0.9999),the method recoveries were 96.87%,97.93% and 95.90% for high,medium and low concentretion;RSD=0.16%(n=9). CONCLUSION This method was found to be accurate,good reproducibility and sensitive for determination of 2-ethlhexanoic residue in Cefodizime Sodium.

关 键 词：头孢地嗪钠 气相色谱 内标物 残留检测 

分 类 号：R927[医药卫生—药学]