注射用头孢唑肟钠中钠离子含量及成盐率测定分析  

Determination of Sodium ion and Salt-forming Rate in Cefazoxime Sodium for Injection by Ion Chromatography

作　　者：王小亮 张伊榕 张秉华 WANG Xiao-liang;ZHANG Yi-rong;ZHANG Bing-hua(Shaanxi Institute for Food and Drug Control,Xi’an 710065,China)

机构地区：[1]陕西省食品药品检验研究院,陕西西安710065

出　　处：《食品与药品》2025年第1期63-67,共5页Food and Drug

基　　金：陕西省食品药品检验研究院青苗培育项目(编号:2024KYYJQ004)。

摘　　要：目的建立离子色谱法测定注射用头孢唑肟钠中钠离子含量及成盐率,并对国产样品成盐率情况进行分析。方法采用Metrohm C_(6)-150/4.0(4.0 mm×150 mm)阳离子分析色谱柱,柱温:30℃;淋洗液:1.7 mmol/L硝酸-1.7 mmol/L吡啶二羧酸,流速:1.2 ml/min;电导检测器;进样量:20μl。结果钠离子在2~15μg/ml浓度范围内线性关系良好,r=0.9999(n=6);检测限为0.04 ng,定量限为0.1 ng;回收率(n=9)为99.5%~99.8%;重复性RSD为1.28%,中间精密度RSD为1.16%;国产28家企业76批注射用头孢唑肟钠的钠含量在5.5%~6.0%之间,其成盐率在0.96~1.04之间,各企业及各批次之间无明显差异。结论所建方法可用于注射用头孢唑肟钠中钠离子的检测,国产注射用头孢唑肟钠成盐工艺控制较好。Objective To establish a method for determination of sodium ion and salt-forming rate in Cefazoxime Sodium for Injection by ion chromatography and analyze the salt-forming rate of domestic samples.Methods A Metrohm C_(6)-150/4.0(4.0 mm×150 mm)cation analysis column was used with 1.7 mmol/L nitric acid-1.7 mmol/L dipicolinic acid as mobile phase.The column temperature was 30℃,and the flow rate was 1.2 ml/min.The conductivity detector was used and the injection volume was 20μl.Results There was a good linear relationship in the range of 2-15μg/ml for sodium ion with r=0.9999(n=6).The LOD was 0.04 ng and the LOQ was 0.1 ng.The recoveries of sodium ion were in the range of 99.5%-99.8%(n=9).The RSD of repeatability test was 1.28%,and the RSD of intermediate precision test was 1.16%.The contents of sodium ion in 76 batches of Cefazoxime Sodium for Injection products from 28 domestic enterprises were in the range of 5.5%-6.0%,and the salt-forming rates were in the range of 0.96-1.04.There were no significant differences in the determination results between different enterprises and batches.Conclusion The method can be used for the determination of sodium ion and the salt-forming rate in Cefazoxime Sodium for Injection.The salt formation process of domestic Cefazoxime Sodium for Injection products is well controlled.

关 键 词：头孢唑肟钠 钠离子 成盐率 离子色谱 

分 类 号：R917[医药卫生—药物分析学]