加校正因子的替代对照品法测定注射用头孢硫脒聚合物  

Determination of polymers in cefathiamidine by substitution of reference substance method with correction factors

作　　者：黄财顺 贺凡珍 王乾蕾 HUANG Cai-shun;HE Fan-zhen;WANG Qian-lei(Zhongshan Institute of Food and Drug Control,Zhongshan Guangdong 528437)

机构地区：[1]中山市食品药品检验所,广东中山528437

出　　处：《中南药学》2022年第6期1417-1421,共5页Central South Pharmacy

基　　金：广东省市场监督管理局科技项目(No.2021CS10)。

摘　　要：目的建立加校正因子的替代对照品法测定注射用头孢硫脒中的聚合物。方法以头孢噻吩作为替代对照品,以紫外吸光系数比值法确定校正因子,以AKTA Prime LC高分子杂质分析仪测定聚合物含量;色谱柱:Sephadex G-10柱(14.0 mm×400 mm);流动相A:pH 8.0的0.2 mol·L^(-1)磷酸盐缓冲液[0.2 mol·L^(-1)磷酸氢二钠溶液-0.2 mol·L^(-1)磷酸二氢钠溶液(61∶39)],流动相B:超纯水;检测波长:254 nm;流速:0.9 mL·min^(-1)。结果头孢噻吩对照品在50~1000 ng·mL^(-1)内与峰面积呈良好的线性关系(r=0.9991),校正因子为0.7804。结论本方法能较好分离头孢硫脒与其聚合物杂质,为加校正因子的替代对照品法在抗菌药物聚合物定量中的应用做了有益探索。Objective To establish the substitution of reference substance method with correction factor to determine the polymers in cefathiamidine.Methods Cefothiophene was used as the substitute reference substance,correction factor was calculated by ultraviolet absorption coefficient,and polymers were detected by AKTA Prime LC.Molecular exclusion chromatography was performed with Sephadex G-10(14.0 mm×400 mm)gel column.The mobile phase A was 0.2 mol·L^(-1)phosphate buffer(pH 8.0)and the mobile phase B was water with a flow rate of 0.9 mL·min^(-1).The detection wavelength was 254 nm.Results The cefothiophene was linearity at 50^(-1)000 ng·mL^(-1)(r=0.9991).The correction factor was 0.7804.Conclusion This method can well separate cefathiamidine and its polymer impurities.It is a good exploration for the determination of polymers by substitution of reference substance method with correction factors.

关 键 词：聚合物 注射用头孢硫脒 头孢噻吩 校正因子 替代对照品法 紫外吸光系数 

分 类 号：R927[医药卫生—药学]