摘要
[目的]确定抗癫痫一类新药Q808主要有关物质的化学结构,并测定含量.[方法]利用HPLC法确定抗癫痫一类新药Q808主要有关物质并进行分离,利用NMR,MS,HSQC,HMBC等光谱法解析主要有关物质的化学结构,进行结构验证并进行含量测定.[结果]确定抗癫痫一类新药Q808主要有关物质为中间体Ⅲ和反应中的副产物6-(2,4-二氯苯氧基)-四唑并[5,1-a]酞嗪,有关物质质量分数均不大于0.05%.[结论]可为抗癫痫新药Q808质量评价提供依据.
OBJECTIVE To determine the structure and content of the related substances in the first type of new anti-epileptic drug Q808. METHODS HPLC was used to determine and isolate the related substances of the first type of new anti-epileptic drug Q808. NMR, MS, HSQC and HMBC were used to determine the structure and the content of the major related substances. RESULTS The major related substances of the first type of new anti-epileptic drug Q808 were intermediate Ⅲ and 6-（2,4- chlorophenoxy）tetrazolo [5,1-a] phthalazine. The mass fraction of the related substances was less than 0.05%. CONCLUSION The study might provide the basis for quality assessment of the new anti-epileptic drug Q808.
出处
《延边大学医学学报》
CAS
2016年第2期103-107,共5页
Journal of Medical Science Yanbian University
关键词
抗癫痫药物
结构鉴定
色谱法
高压液相
antiepileptic drugs
structure identification
chromatography, high pressure liquid
