注射用头孢唑肟钠的高分子聚合物检查方法的建立与验证  

Development and validation for determination of high molecular polymers concentration in Ceftizoxime Sodium Injection

作　　者：姚蕾[1] 顾立素[1] 胡昌勤[1] 

机构地区：[1]中国药品生物制品检定所,北京100050

出　　处：《药品评价》2007年第6期428-431,共4页Drug Evaluation

摘　　要：目的建立对头孢唑肟钠中高分子聚合物进行分离分析的质量控制方法,并对其进行验证。方法采用凝胶色谱法,色谱柱为SephadexG10,流动相A为0.1mol/L磷酸盐缓冲液(pH7.0),流动相B为水;流速为每分钟0.8ml;检测波长为254nm,进样量为200μl,自身对照外标法定量。结果验证了头孢唑肟钠高分子聚合物检测方法,采用该方法对3批样品中高聚物含量的进行检测的结果均小于0.1%。结论该方法能够较好的分离头孢唑肟钠和高聚物,可用于注射用头孢唑肟钠中高分子聚合物的检验。Objective TO development and validate the method of separating and determining the high molecular polymers in ceftizoxime sodium for quality control. Methods Gel filtration chromatography was performed by using Sephadex G10 gel colum. The mobile phase was consisted of A, 0.1 mol/L phosphate buffer （pH=7.0）; and B, water. The flow rate wan 0.8ml/min, the detection wavelength was 254nm and the injection volum was 200μ1. The concentration of polymers was quantified by external standard method of reference oneself. Results The determining method was validated, and the concentration of polymers in there batches of ceftizoxime sodium injection were less than 0.1%. Conclusion This method can be separating the polymers form cefiizoxime sodium preferably, and is suitable for controlling the quality of this drug.

关 键 词：头孢唑肟钠 高分子聚合物 凝胶色谱法 

分 类 号：R927[医药卫生—药学]