摘要
目的对丙二醇头孢曲嗪的杂质进行结构确证。方法高效液相色谱法(HPLC)对有关物质进行初步定性分析;经制备液相制备杂质Ⅰ,经定向合成及制备液相制备杂质Ⅱ,采用UV、IR、MS、NMR等分析手段对各杂质进行综合结构解析。结果杂质Ⅰ经结构解析为D-对羟基苯甘氨酸,杂质Ⅱ为头孢曲嗪的差向异构体。结论头孢曲嗪的杂质结构确证对丙二醇头孢曲嗪的质量控制具有重要意义。
OBJECTIVE To confirm the structures of the impurities of cefatrizine propylene glycolate. METHODS HPLC was employed to do a preliminary qualitative analysis of the related substances, preparative liquid chromatography was used to prepare impurity Ⅰ , and oriented synthesis and preparative liquid chromatography were used to prepare impurity Ⅱ. Then, UV, IR, MS and NMR and other analytical tools were used to comprehensively analyze the structures of the impurities. RESULTS hupurity Ⅰ was confirmed as 4-hydroxyphenylglycine, and impurity Ⅱwas confirmed as epimeride of cefatrizine. CONCLUSION This study of impurities has important significance for the quality control of cefatrizine propylene glycolate.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2014年第23期2112-2119,共8页
Chinese Pharmaceutical Journal
基金
"国家重大新药创制"科技重大专项(20112X09401-403)
