TSK凝胶色谱系统测定注射用头孢唑林钠的聚合物及有关物质  

Determination of the polymer and related substances in Cefazolin Sodium for Injection by TSKgel G2500PWXL column

作　　者：陈星[1] 

机构地区：[1]福建省药品检验所,福州350001

出　　处：《海峡药学》2010年第10期39-41,共3页Strait Pharmaceutical Journal

摘　　要：目的建立TSK凝胶色谱系统测定注射用头孢唑林钠的聚合物及有关物质的方法。方法色谱柱为TSKgel G2500PWXL(7.8mm×30.0cm),流动相:0.1mol.mL-1磷酸盐缓冲液(pH7.0),流速为0.5mL.min-1,检测波长为254nm,进样量为10μL。结果头孢唑林聚合物、保留时间小于头孢唑啉峰的各杂质峰及头孢唑林峰在此色谱条件下分离良好,可对聚合物总量(Kav<0.3)、保留时间小于头孢唑林的各杂质峰面积的和进行同时测定。结论该方法简便,准确,灵敏度高,重现性好,可用于注射用头孢唑林钠的质量控制。OBJECTIVES To establish a method for determination of the polymers and related substances in Cefazolin Sodium for injection.The Chromatographic column was TSKgel G2500PWXL（7.8mm×30.0cm）,mobile phase：0.1mg·mL^-1 phosphate buffer（pH7.0）;the flow rate was 0.5 mL·min^-1,the detection wavelength was 254nm and the injection volume was 10μL;RESULTS Good separation of Cefazolin,Polymer and Related substances.CONCLUSIONS The method is simple,accurate,sensitive and reproducible.It can be used for the quality control of Cefazolin Sodium for Injection.

关 键 词：头孢唑林钠 聚合物 有关物质 TSKgelG2500PWXL 

分 类 号：R927.2[医药卫生—药学]