离子色谱法测定头孢噻吩钠中钠离子含量以及成盐率考察  

Determination of Sodion and Salt-forming Rate in Cefalotin Sodium by Ion Chromatography

作　　者：闻宏亮[1] 赵敬丹[1] 秦峰[1] 裘亚[1] 刘浩[1] 杨美成[1] 

机构地区：[1]上海市食品药品检验所,上海201203

出　　处：《中国药师》2015年第2期212-215,共4页China Pharmacist

基　　金：十二五国家重大新药创制项目(编号:2011ZX09303-001)

摘　　要：目的：建立离子色谱法测定头孢噻吩钠中的钠离子含量,并考察其成盐状态。方法：分析柱为TSKgel Super IC-CR阳离子柱（150 mm×4.6 mm,3.0μm）,流动相为2.2 mmol·L-1甲烷磺酸与1 mmol·L-118-冠-6-醚的混合溶液,流速为0.8 ml·min-1,柱温为40℃,进样量为20μl。检测器为电导检测器。结果：钠离子在3.0~60.0μg·ml-1范围内线性关系良好（r=0.999 9）,平均回收率为99.8%（RSD=0.8%,n=9）。样品中钠离子与头孢噻吩酸的摩尔数比在0.97~1.03之间。结论：所建立的离子色谱法专属性强,精密度好,准确度高,可用于头孢噻吩钠中钠离子定量测定。8批样品的成盐状态良好。Objective： To establish a method for the determination of sodion in cefalotin sodium by ion chromatography and investigate the salt-forming rate of the products. Methods： A TSKgel Super IC-CR cation exchange column（ 150 mm × 4. 6 mm,3. 0 μm） was used. The mobile phase was the mixture of 2. 2 mmol·L- 1methanesulfonic acid and 1 mmol·L- 118-crown-6-ether with the flow rate of 0. 8 ml·min- 1. The column temperature was 40℃ and the injection volume was 20 μl. The detector was an electric conductivity detector. Results： The linear correlation of sodion was good within the range of 3. 0-60. 0 μg·ml- 1（ r = 0. 999 9）. The average recovery was 99. 8%（ RSD = 0. 8%,n = 9）. The mole number ratio of sodion to cefalotin was within the range of 0. 97-1. 03. Conclusion：The method is specific,precise and accurate,and can be used in the determination of sodion in cefalotin sodium. The salt-forming rate of the 8 batches of samples is promising.

关 键 词：离子色谱法 头孢噻吩钠 钠离子 成盐率 

分 类 号：R917[医药卫生—药物分析学]