TSK凝胶色谱法测定头孢妥仑匹酯片中的聚合物  

Determination of the polymers of cefditoren pivoxil tablets by TSK-gel chromatography G2000HHR

作　　者：李敏 贾玉捷 杨宏硕 马亚松 胡利敏 Li min;Jia Yujie;Yang Hongshuo;Ma Yasong;Hu Limin(NCPC Hebei Huamin Pharmaceutical Corporation Ltd.,Shijiazhuang 052165,China)

机构地区：[1]华北制药河北华民药业有限责任公司,石家庄052165

出　　处：《煤炭与化工》2020年第6期147-149,154,共4页Coal and Chemical Industry

摘　　要：建立了采用TSK凝胶色谱法测定头孢妥仑匹酯片中聚合物含量的方法。实验条件:采用TSK-gel G2000HHR(300 mm×7.8 mm,5μm),以30 mmol/L溴化锂N,N-二甲基甲酰胺溶液为流动相,流速为0.3 m L/min,检测波长为280 nm,柱温为25℃。实验结果表明,该方法验证结果良好,头孢妥仑匹酯在0.02~148.03μg/ml范围内呈良好的线性关系,线性方程为y=85812 x-18862,r=0.9996;检测限为0.01μg/m L,定量限为0.03μg/m L。本方法灵敏、准确,专属性强,适用于头孢妥仑匹酯片中聚合物的测定。A method for determination of polymer content in cefditoren pivoxil tablets by TSK gel chromatography was established.Experimental conditions:using a TSK gel G2000 HHR column(300 mm×7.8 mm,5μm),the mobile phase is30 mmol/L solution of lithium bromide in N,N-dimethylformamide for liquid chromatography at the flow rate of 0.3 m L/min,the detection wavelength is 280 nm,the column temperature is 25℃.The results show that the linear range of cefditoren pivoxil is in the range from 0.02 to 148.03μg/m L,linear equation is y(area of peak)=85812 x(concentration)-18862,r=0.9996.The detection limit is 0.01μg/m L,the quantification limit is 0.03μg/m L.The method is sensitive,accurate and specific,is suitable for detecting the polymers in cefditoren pivoxil tablets.

关 键 词：TSK凝胶色谱法 头孢妥仑匹酯片 聚合物 验证 

分 类 号：TQ465.1[化学工程—制药化工]