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凝胶色谱法测定注射用头孢孟多酯钠中高分子聚合物的含量
引用本文:陈燕,吕旭幸,王丽云,张韬. 凝胶色谱法测定注射用头孢孟多酯钠中高分子聚合物的含量[J]. 海峡药学, 2011, 23(12): 74-76
作者姓名:陈燕  吕旭幸  王丽云  张韬
作者单位:1. 浙江亚太药业股份有限公司 绍兴 312030
2. 西安理工大学 西安 710048
摘    要:目的 建立以凝胶色谱法测定注射用头孢孟多酯钠中的高分子聚合物的方法.方法 采用凝胶色谱柱,色谱柱为Sephadex G-10(15.0mm×300mm),流动相A为pH 7.0的0.01mol·L-1磷酸盐缓冲液,流动相B为水,流速为每分钟1.4mL,检测波长为254nm,进样量为200μL.结果 验证了头孢孟多酯钠高...

关 键 词:头孢孟多酯钠  高分子聚合物  凝胶色谱法

Determination of high molecular polymer concentration in Cefamandole Nafate for Injection by gel chromatography
CHEN Yan , LV Xu-xin , WANG Li-yun , ZHANG Tao. Determination of high molecular polymer concentration in Cefamandole Nafate for Injection by gel chromatography[J]. Strait Pharmaceutical Journal, 2011, 23(12): 74-76
Authors:CHEN Yan    LV Xu-xin    WANG Li-yun    ZHANG Tao
Affiliation:1.Zhejiang Yatai Pharmaceutical Co.Ltd,Shaoxing 312030,China;2.Xi′an University of technolog Xi′an 710048,China)
Abstract:OBJECTIVE To establish a method to determine the polymers in Cefamandole Nafate.METHODS Gel filtration chromatography was per-formed by using Sephadex G-10(15.0mm×300mm).The mobile phase was cons-isted of A,0.01mol·L-1 phosphate buffer(pH=7.0);and B,water.The flow rate was 1.4mL·min-1,the detection wavelength was 254nm and the injection volum was 200μL.RESULTS The determining method was validated,and the concentration of polymers in there batches of Cefamandole Nafate for Inje-ction were less than 0.05%.CONCLUSION The method is simple,accurate,sensitive and repeatable,and is suitable for controlling the quality of this drug.
Keywords:Cefamandole Nafate  High molecular polymers  Gel filtration chromatography
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