摘要
根据非洛地平高效液相色谱的信息，利用气相色谱－质谱法，初步确定非洛地平成品中的两个杂质可能为同系物４－（２，３－二氯苯基）－１，４－二氢－２，６－二甲基－３，５－吡啶二羧酸甲酯（Ⅰ）和４－（２，３－二氯苯基）－１，４－二氢－２，６－二甲基－３，５－吡啶二羧酸乙酯（Ⅱ）；并用化学方法合成了化合物（Ⅰ）和（Ⅱ），再经ＨＰＬＣ测定，通过比较它们之间的保留时间，进一步确证了非洛地平成品中的两个杂质分别为化合物（Ⅰ）和（Ⅱ）。
Based on the information of GC/MS of felodipine sample,we inferred that one of impurities(a) in felodipine sample was derivative methyl 1,4-dihydro-2,6-dimethyl-4-(2,3-dichlorophenyl)3,5-pyridinedicarboxylate(Ⅰ),the other(b) was derivative ethyl 1,4-dihydro-2,6-dimethyl-4-(2,3-dichlorophenyl)-3,5-pyridinedicarboxylate(Ⅱ).Compounds(Ⅰ) and(Ⅱ)were synthesized and compared with the impurities(a)and(b) in felodipine sample by HPLC method. Results showed that impurity(a)was identical to compound(Ⅰ) and impurity(b)was identical to compound(Ⅱ).
出处
《中国药科大学学报》
CAS
CSCD
北大核心
1995年第2期65-67,共3页
Journal of China Pharmaceutical University
基金
国家医药管理局资助
