摘要
目的对苄星青霉素杂质C进行制备研究。方法 利用苄星青霉素母液,经减压蒸馏、柱色谱、重结晶制备苄星青霉素杂质C,采用UV、IR、MS、NMR、元素分析确证结构,HPLC测定纯度和校正因子,外标法测定样品。结果 制备产物经结构确证为苄星青霉素杂质C。结论苄星青霉素杂质C的制备对苄星青霉素的有关物质控制具有重要意义。
OBJECTIVE To prepare impurity C in benzathine benzylpenicillin products. METHODS Using the mother liquor of benzathine benzylpenicillin, impurity C was prepared by means of vacuum distillation, column chromatography, and recrystalfiza- tion. Its molecular structure was confirmed with UV, IR, MS, NMR and elemental analysis. Its purity and correction factor were determined by HPLC method. The contents of impurity C in the samples were determined by external standard method. RESULTS The prepared product was proved to be impurity C by structure confirmation. CONCLUSION The preparation of impurity C in benzathine benzylpenicillin products has important significance for the control of related substances of benzathine benzylpenicillin products.
出处
《中国药学杂志》
CAS
CSCD
北大核心
2013年第12期1010-1014,共5页
Chinese Pharmaceutical Journal
基金
河北省科技支撑计划项目资助(06276425)
关键词
苄星青霉素
杂质C
制备
结构确证
benzathine benzypenieillin
impurity C
preparation
structure confirmation
