塞克硝唑的质量标准研究  

Study on the Quality Standard of Secnidazole

作　　者：潘勇[1] 何鸽飞 郑金凤 童达 邱细敏[4] 

机构地区：[1]湖南省肿瘤医院,长沙410013 [2]长沙市第一医院,长沙410005 [3]湖南省食品药品检验院,长沙410001 [4]湖南师范大学医学院药学系,长沙410005

出　　处：《中国药房》2015年第9期1266-1268,共3页China Pharmacy

摘　　要：目的:建立塞克硝唑的质量标准。方法:分别采用理化鉴别法、紫外光谱和红外光谱对塞克硝唑进行鉴别;采用气相色谱法(GC)、高效液相色谱法(HPLC)对残留溶剂、有关物质等进行检查;采用非水滴定法测定塞克硝唑的含量。结果:塞克硝唑理化鉴别的专属性强,紫外光谱和红外光谱鉴别方法均可行;按外标法以峰面积计算未检测到残留溶剂;以Agilent C18为色谱柱,甲醇-水(20∶80,V/V)为流动相,主峰能与相邻杂质峰很好地分离;非水滴定法测得每1 ml的高氯酸滴定液(0.1 mol/L)相当于18.52mg的塞克硝唑(C7H11N3O3)。结论:本方法统一了塞克硝唑的性状、鉴别、检查与含量测定方法,可为其质量标准的修订提供参考。OBJECTIVE：To establish the quality standard of secnidazole. METHODS：The physiochemical identification,UV spectrum and IR spectrum were used for the identification of secnidazole,respectively. The residual solvents and the related substances were determined by GC and HPLC. Besides,the content of secnidazole was determined by the non-aqueous titration method. RESULTS：The physiochemical identification had strong specificity,the UV and IR spectrums were workable. The residual solvents had not been detected by using the external standard method with peak area calculation. Performed on the Agilent C18 column with the mobile phase of methanol-water（20∶80,V/V）,main peak was completely separated from the adjacent impurity peak. According to non-aqueous titration method,per 1 ml of perchloric acid solution（0.1 mol/L）was equivalent to 18.52 mg of secnidazole（C7H11N3O3）. CONCLUSIONS：The article unifies the characters,identification,examination and content determination method of secnidazole and can provide reference for the revision of quality standard.

关 键 词：塞克硝唑 有关物质 电位滴定法 质量标准 

分 类 号：R927.11[医药卫生—药学]