异戊巴比妥的杂质研究和化学合成

摘要

使用中国药典2010版HPLC方法对异戊巴比妥进行分析，可以检测到两个明显的杂质。依据生产工艺对杂质进行了结构推断和产生原因分析并对杂质进行了合成。通过对合成杂质与异戊巴比妥杂质HPLC和MS分析比对，确定异戊巴比妥中主要杂质为异戊巴比妥的同分异构体[5-乙基-5-（2-甲基丁基）巴比妥酸]和双异戊巴比妥[5，5-二（3-甲基丁基）巴比妥酸]。%Amobarbital was impurities were detected. analyzed by HPLC method described in CP2010 monograph and 2 main The structures of the impurities and the cause of impurities formed were deduced according to the manufacturing process of amobarbital; meanwhile the impurities were also synthesized. By comparison with the HPLC chromatograms and MS spectrums of the synthesized impurities, it was confirmed that the main impurities contained in amobarbital were the isomer of amobarbital - [ 5 - ethyl - 5 - （ 2 - methyl butyl） barbituric acid ] and bisamobarbital - [ 5, 5 - 2 （ 3 - methyl ethyl） barbituric acid].