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头孢拉定聚合物测定方法的研究
引用本文:韩秀梅,祖述春,王莉,盛秀红.头孢拉定聚合物测定方法的研究[J].西北药学杂志,2012,27(5):422-424.
作者姓名:韩秀梅  祖述春  王莉  盛秀红
作者单位:秦皇岛市食品药品检验中心;秦皇岛市第一医院;秦皇岛市海港医院
摘    要:目的建立了分子排阻色谱方法测定头孢拉定高分子聚合物。方法采用SephadexG-10色谱柱;流动相A:6g.L-1醋酸钠溶液,流动相B:水;流速:1.0mL.min-1;检测波长:254nm;柱温:室温。结果头孢拉定在6.432~75.39mg.mL-1范围内与头孢拉定高分子聚合物峰面积呈良好的线性关系(r=0.998 1)。结论该方法简便、快速、准确可靠,能有效地控制头孢拉定高分子聚合物的含量,可作为头孢拉定高分子聚合物的质量控制方法。

关 键 词:分子排阻色谱法  头孢拉定  高分子聚合物  方法学验证

Research on the determination method of cefradine polymer
HAN Xiumei,ZU Shuchun,WANG Li,SHENG Xiuhong.Research on the determination method of cefradine polymer[J].Northwest Pharmaceutical Journal,2012,27(5):422-424.
Authors:HAN Xiumei  ZU Shuchun  WANG Li  SHENG Xiuhong
Institution:1.Qinhuangdao Institute for Food and Drug Control,Qinhuangdao 066004,China;2.Qinhuangdao Number One Hospital,Qinhuangdao 066000,China,3.Qinhuangdao Haigang Hospital Qinhuangdao 066000,China)
Abstract:Objective To establish a molecular-exclusion chromatography method for the determination of cefradine polymer.Methods Mobile phase A was 6 g·L-1 natrium acetum solution,mobile phase B was water,the flow rate was 1.0 mL·min-1,the detection wavelength was 254 nm,and the column temperature was room temperature.Results Calibration curve of cefradine polymer was linear over the range of 6.432-75.39 mg·mL-1(r=0.998 1).Conclusion The established method is simple,quick and accurate,it can be used effectively to control the cefradine polymer.
Keywords:HPSEC method  cefradine  high polymer  method validation
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