A paper from Emcure
Four isomeric unknown impurities ranging from 0.08-0.12% were found in the purified sample of Zolmitriptan during the batch analysis by gradient reverse phase ultra performance liquid chromatography (UPLC) and their molecular weights determined by liquid chromatography mass spectroscopy (LC-MS) analysis. Subsequently, all the four impurities were isolated by flash chromatography followed by semi-preparative HPLC and characterized by 1H NMR, 13C NMR, 1H-1H COSY, HMBC, HSQC, MS spectroscopy and HPLC. The structures for these four impurities were assigned to be following
Isomeric Impurity-1: 4-((3-(2-(dimethylamino)ethyl)-4-(2-((oxazolidin-4-yl)methyl)phenyl)-1H-indol-5-yl)methyl) oxazolidin-2-one,
Isomeric Impurity-2: 4-((3-(2-(dimethylamino)ethyl)-2-(4-((oxazolidin-4-yl)methyl)phenyl)-1H-indol-5-yl)methyl) oxazolidin-2-one-,
Isomeric Impurity-3: 4-((3-(2-(dimethylamino)ethyl)-7-(4-((oxazolidin-4-yl)methyl)phenyl)-1H-indol-5-yl)methyl) oxazolidin-2-one,
Isomeric Impurity-4: 4-((3-(2-(dimethylamino)ethyl)-6-(4-((oxazolidin-4-yl)methyl)phenyl)-1H-indol-5-yl)methyl) oxazolidin-2-one
Isolation and characterization of impurities has helped us in improving the purity of API by removing these impurities using crystallization.
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API Research Centre
Emcure Pharmaceutical Limited
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|Volume 4, Issue 2|
Mukund Keshao Gurjar
Dr. Mukund Gurjar is an Executive Director and Chief Scientific Officer (Research and Development) of this Company(Emcure). He is a graduate, a post graduate and Ph.D. in Chemistry from the Nagpur University. He also holds a second Ph. D. degree in Chemistry from the London University, United Kingdom as well as a post doctoral fellowship from Toronto, Canada. Prior to joining our Company, he was the deputy director of the National Chemical Laboratory, Pune where he spent 25 years spearheading innovative and advance research in Organic Chemistry. He has over 32 years of experience in pharmaceutical sciences and is a fellow at various national and international academies. He is a member of the editorial board of the prestigious journal Organic Process Research & Development published by the American Chemical Society. For his contributions to synthetic organic chemistry involving both basic and applied research, he has been felicitated with various awards. A large number of students have obtained Ph.Ds under the supervision of Dr. Gurjar and has published more than 200 papers in various international journals. He has been associated with our Company since 2001 and also became a member of the Board in the same year.