Application of Multiple Methods in Characterizing Leflunomide Assay
LIU Yang1, LI Jie1, WU Zhen1,2, ZHAO Zhuang3, HE Lan1
1. National Institutes for Food and Drug Control, Beijing 102629, China;
2. The Experimental High School Attached to Beijing Normal University, Beijing 100032, China;
3. Guangxi Institute for Food and Drug Control, Nanning 530021, China
Abstract Mass balance method(MB), 19F quantitative nuclear magnetic resonance (19F-qNMR) and differential scanning calorimeter (DSC)were used to determine the content and purity of leflunomide. The result from 19F-qNMR (100.2%) is similar to that from MB (99.7%). Meanwhile, the purity result from DSC (99.92%) is comparable to that from HPLC test (99.78%). All the three methods could be used to characterize the assay or purity of leflunomide. The methods could be applied to confirm each other and improve the drug quality control.
LIU Yang, LI Jie, WU Zhen, ZHAO Zhuang, HE Lan. Application of Multiple Methods in Characterizing Leflunomide Assay[J]. Chinese Journal of Chemical Education, 2018, 39(10): 33-35.
