Preparation process and structure confirmation of impurity C of rupatifen fumarate
10.11665/j.issn.1000-5048.20200504
- VernacularTitle:富马酸卢帕替芬杂质C制备工艺和结构确证
- Author:
Lin LI
1
;
Xiaoming WANG
;
Shufang MENG
;
Lin CHEN
;
Haiyan WANG
;
Pengfei LIN
;
Ling CHEN
Author Information
1. 福建省闽东力捷迅药业有限公司
- Publication Type:Journal Article
- Keywords:
rupatifen fumarate;
impurity C;
preparation process;
structure confirmation;
nuclear magnetic resonance;
high resolution mass spectrometry
- From:
Journal of China Pharmaceutical University
2020;51(5):530-537
- CountryChina
- Language:Chinese
-
Abstract:
The high-purity impurity C was isolated and purified from a new anti-allergic drug, rupatifen, by nucleophilic substitution reaction with bromobutaric acid, and its structure was confirmed by IR, UV, MS, 1H NMR, 13C NMR, DEPT135°,HSQC, HMBC, and 1H-1HCOSY. The preparation process of impurity C in this study was simple and easy to obtain under mild conditions, with the purity of 99.0% and the yield of 25%-30%;and the sample met the target compound by structural confirmation. The preparation process and structure confirmation provided sufficient impurity C reference substance for impurity research of raw materials and preparations of rupatifen fumarate, which laid a solid foundation for quality research of new drugs.
