高效凝胶色谱法测定注射用头孢哌酮钠他唑巴坦钠中的高聚物  

Determination of Polymers in Cefoperazone Sodium and Tazobactam Sodium for Injection by High Performance Gel Chromatography

作　　者：王全一[1] 李彦博[1] 傅蓉[1] 

机构地区：[1]辽宁省食品药品检验所,辽宁沈阳110023

出　　处：《中国药业》2013年第12期83-84,共2页China Pharmaceuticals

摘　　要：目的建立测定注射用头孢哌酮钠他唑巴坦钠(4∶1)中高聚物的高效凝胶色谱法。方法采用Ohpak SB-802.5HQ凝胶色谱柱,以pH=7.0的磷酸盐缓冲液[0.03 mol/L磷酸氢二钠溶液-0.03 mol/L磷酸二氢钠溶液(61∶39)]-乙腈(70∶30)为流动相,主成分自身对照法定量。结果建立了在该系统下以保留时间小于头孢哌酮钠所有杂质峰面积的总和进行质量控制的检测方法。结论所用方法简便,结果可靠,可用于注射用头孢哌酮钠他唑巴坦钠(4∶1)中高聚物的检测。Objective To establish a method for the determination of the polymers impurities in Cefoperazone Sodium and Tazobactam Sodium for Injection（4：1）. Methods The analytical column was the Ohpak SB- 802.5HQ gel chromatographic column and the mobile phase was composed of phosphate buffer（pH =7.0,0.03 mol/L,61：39）- acetonitrile（70：30）. The main component was quantified by the self- contrasted method. Results The detection method was established under this system, in which the retention time less than the sum of all impurity peak areas of cefoperazone sodium was selected for conducting the quality control. Conclusion The used method is simple with reliable detection results, and applicable for the polymers detection of Cefoperazone Sodium and Tazobactam Sodium for In- jection（4 ： 1）.

关 键 词：头孢哌酮钠 他唑巴坦钠 高聚物 高效凝胶色谱 

分 类 号：R927.2[医药卫生—药学] R978.11