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.
出处
《药品评价》
CAS
2007年第6期428-431,共4页
Drug Evaluation
关键词
头孢唑肟钠
高分子聚合物
凝胶色谱法
Ceftizoxime sodium
High molecular polymers
Gel filtration chromatography
作者简介
姚蕾（1975-），女，北京人，硕士。助理研究员，从事抗生素药品质量控制及分析研究。
