测定注射用头孢地嗪钠中聚合物含量的两种HPSEC法比较  

Comparative study on the determination of polymer in Cefodizime sodium for injection by two HPSEC method

作　　者：熊雯 张洁 袁宇琳 XIONG Wen;ZHANG Jie;YUAN Yulin(Food and Drug Research Institute of Chengdu,Chengdu,Sichuan,610045 P.R.China)

机构地区：[1]成都市食品药品检验研究院,四川成都610045

出　　处：《华西药学杂志》2020年第2期201-204,共4页West China Journal of Pharmaceutical Sciences

基　　金：符合国际规范的制剂分析与质量控制及标准研究公共服务平台项目(2018ZX09201018-023)。

摘　　要：目的采用高效分子排阻色谱法(HPSEC)测定注射用头孢地嗪钠中的聚合物。方法比较两种HPSEC法测定注射用头孢地嗪钠中聚合物的含量,建立最优的测定方法。方法一:以葡聚糖凝胶G-10(300 mm×10 mm)为固定相,以0.025 mol·L-1磷酸氢二钠-0.025 mol·L-1磷酸二氢钠(61:39)磷酸盐缓冲液(pH7.0)为流动相A,水为流动相B,流速1.0 mL·min-1,检测波长为254 nm。方法二:以TSKgel G2000SWXL(300 mm×7.8 mm)为固定相,流动相为pH7.0磷酸盐缓冲液[5 mmol·L-1磷酸氢二钠-5 mmol·L-1磷酸二氢钠(61:39)]-乙腈(95:5),流速为1.0 mL·min-1,检测波长231 nm。结果在方法二的条件下,高分子杂质与头孢地嗪钠能有效分离,且较方法一检测出更多杂质峰。0.2~250μg·mL-1头孢地嗪与峰面积呈良好的线性关系(r=0.9990)。结论方法二的专属性好、灵敏度高、操作简便,用于测定头孢地嗪钠中的聚合物时,能更全面地反映头孢地嗪钠中高分子杂质的情况,可有效地控制产品的质量。OBJECTIVE To establish a method for the determination of polymer of cefodizime sodium for injection by HPSEC method.METHODS Study and compare for determination of polymer in cefodizime sodium for injection by two methods,to establish a best method.Method 1 was as follow Sephadex G-10(300 mm×10 mm) was used as stationary phase,phosphate buffer(pH7.0)[0.025 mol·L-1 disodium hydrogen phosphate-0.025 mol·L-1 sodium dihydrogen phosphate(61:39)] was used as mobile phase A,and water was used as mobile phase B.The flow rate was 1.0 mL·min-1.The detection wavelength is 254 nm.Method 2 was as follow TSKgel G2000 SWXL(300 mm×7.8 mm) was used as stationary phase,phosphate buffer [5 mmol·L-1disodium hydrogen phosphate-5 mmol·L-1 sodium dihydrogen phosphate(61:39),pH7.0]-acetonitrile(95:5) was used as mobile phase,and the flow rate was 1.0 mL·min-1.Detection wavelength was 231 nm.RESULTS Under the condition of method 2,polymer impurities can be effectively separated from cefodizime sodium,and more impurity peaks can be detected than method 1.Cefodizime has a good linear relationship between peak area and concentration in the concentration range of 0.2-250 μg·mL-1(r=0.9990).CONCLUSION HPSEC method is accurate,sensible and reproducible,and is suitable for the quality control.

关 键 词：头孢地嗪钠 聚合物 高效空间排阻色谱法 比较研究 注射用 含量 质量控制 高分子杂质 

分 类 号：R917[医药卫生—药物分析学]