高效分子排阻法测定注射用头孢唑肟钠聚合物的方法学研究  

Methodological study on high-performance size-exclusion chromatography in determination of ceftizoxime sodium polymer for injection

作　　者：孔令洋 韩勇 孙巧巧 王冉 李正国 KONG Lingyang;HAN Yong;SUN Qiaoqiao;WANG Ran;LI Zhengguo(Jining Food and Drug Inspection and Testing Research Institute,Shandong,Jining 272027,China;Institute of Chinese Meteria Medica,China Academy of Chinese Medical Sciences,Beijing 100700,China)

机构地区：[1]山东省济宁市食品药品检验检测研究院,山东济宁272027 [2]中国中医科学院中药研究所,北京100700

出　　处：《中国医药科学》2022年第13期98-100,114,共4页China Medicine And Pharmacy

基　　金：山东省药品质量安全风险监测评估项目(19);2021年山东省市场监督管理局科研项目。

摘　　要：目的 建立高效分子排阻法测定头孢唑肟钠聚合物的检测方法。方法 采用东曹TSKgelG2000SWXL亲水硅胶色谱柱(分子量范围1000~10 000),流动相pH 7.0的磷酸盐缓冲液[0.075 mol/L磷酸二氢钠-0.075mol/L磷酸氢二钠(39∶61)-乙腈(90∶10)],柱温:30℃,检测波长:254 nm。结果 经四种破坏处理后,头孢唑肟的降解产物均能与主峰有效分离,方法专属性良好。头孢唑肟主峰的线性范围为0.5~20 mg/ml,检测限为0.25μg/ml,定量限为0.75μg/ml,精密度良好。结论 该方法准确、灵敏,简便易行,且分析时间较短,可用于头孢唑肟钠聚合物的测定。Objective To establish high-performance size-exclusion chromatography(HPSEC) for the determination of ceftizoxime sodium polymer. Methods Dongcao TSKgelG2000SWXL hydrophilic silica gel chromatographic column(molecular weight range: 1000-10 000) was used. The mobile phase was phosphate buffer with a pH of 7.0 [0.075mol/L sodium dihydrogen phosphate-0.075mol/L disodium hydrogen phosphate(39:61)-acetonitrile(90:10)], the column temperature was 3 0 ℃, and detection wavelength was 254 nm. Results After four kinds of destructive treatments, the degradation products of ceftizoxime were effectively separated from the main peak with good specificity. The linear range of the main peak of ceftizoxime was from 0.5 to 20 mg/ml, the detection limit was 0.25 μg/ml, and the quantitative limit was 0.75 μg/ml, which showed a satisfactory precision. Conclusion HPSEC method is accurate, sensitive, simple and easy to operate, and requires a short time for analyses, which can be used for the determination of ceftizoxime sodium polymer.

关 键 词：高效分子排阻法 头孢唑肟钠 聚合物 分子量范围 

分 类 号：R927.1[医药卫生—药学]