头孢羟氨苄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 cefadroxil

作　　者：臧洪梅[1] 

机构地区：[1]安徽医科大学药学院,合肥230032

出　　处：《中国抗生素杂志》2010年第6期450-452,461,共4页Chinese Journal of Antibiotics

摘　　要：目的建立对头孢羟氨苄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Sephadex G10,流动相A为0.lmol/L磷酸盐缓冲液(pH7.0),流动相B为水;流速为0.6mL/min(采用流动相A时,20min后流速增为2mL/min);检测波长为254nm,进样量为200μL,以头孢拉定作对照加校正因子法外标法定量(头孢羟氨苄:头孢拉定=1:1)。结果验证了头孢羟氨苄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进行检测结果均小于0.05%。结论该法较好的分离头孢羟氨苄及其高聚物,可用于头孢羟氨苄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 cefadroxil for quality control. Methods Gel filtration chromatography was performed by using Sephadex G10 gel column. The mobile phase was consisted of A, 0.1 mol/L phosphate buffer （pH7.0） and B, water. The flow rate was 0.6mL/min （up to 2mL/min after 20minutes with mobile phase A）, the detection wavelength was 254nm and the injection volume was 200gL. The concentration of polymers was quantified by external standard method of cefaradine with a correct factor （ cefadroxil ： cefaradine = 1：1）. Results The determining method was validated and the concentrations of the polymers in three batches of were less than 0.05%. Conclusions This method can be used to separate the polymers from cefadroxil preferably and control the quality of the agent.

关 键 词：头孢羟氨苄 高分子聚合物 凝胶色谱 

分 类 号：R978.11[医药卫生—药品]