塞克硝唑的质量标准研究

发布时间：2018-01-25 03:03

  本文关键词： 塞克硝唑 有关物质 电位滴定法 质量标准　出处：《中国药房》2015年09期 　论文类型：期刊论文

【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。
[Abstract]:Objective: to establish the quality standard of Seek nitrazole. Methods: physical and chemical identification, UV spectrum and infrared spectrum were used to identify Seek nidazole. The residual solvents and related substances were detected by gas chromatography (GC) and high performance liquid chromatography (HPLC). The content of Seek nitrazole was determined by non-aqueous titration. Results: Seek nitrazole had strong specificity in physical and chemical identification and could be identified by UV and IR spectra. No residual solvent was detected according to the peak area calculated by external standard method. Using Agilent C18 as chromatographic column and methanol-water 20: 80 V / V) as mobile phase, the main peak can be well separated from the adjacent impurity peak. The titration of perchloric acid per 1 ml is equal to 18.52 mg of Seek niazolium C _ 7H _ 11N _ 3O _ 3) by non-aqueous titration. Conclusion: this method unifies the character of Seek nitrazole. The methods of identification, inspection and content determination can provide reference for the revision of its quality standard.
【作者单位】： 湖南省肿瘤医院;长沙市第一医院;湖南省食品药品检验院;湖南师范大学医学院药学系;
【分类号】：R927;O657
【正文快照】： 塞克硝唑(Secnidazole)化学名是1-(2-羟基丙基)-2-甲基-5-硝基咪唑,具有抗多种厌氧菌和原虫的作用,特别是溶解宿主组织内阿米巴病、贾第鞭毛虫等[1-2]。该药由罗纳普朗克乐安(Rhone-Poulenc Rorer)公司研制,于1980年在瑞士上市。我国塞克硝唑的现有质量标准为国家食品药品监督，

本文编号：1461807