Journal :   Asian Journal of Research in Chemistry

Volume No. :   3

Issue No. :  2

Year :  2010

Pages :   395-397

ISSN Print :  0974-4169

ISSN Online :  0974-4150


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A Sensitive and Selective GC-MS Method for the Determination of Process Related Genotoxic Impurities in Esomeprazole Magnesium



Address:   Yogeshwar Reddy M1,3*, Ramesh V2, Kista Reddy Ch3, Suryanarayana M.V1, Dilip Kumar M1, Raju G2 , Saravanan G1 and Debashish Datta1
1Matrix Laboratories Ltd., R and D centre, Jinnaram mandal, Medak, 502325, India
2National Centre for Mass Spectrometry, Indian Institute of Chemical Technology, Hyderabad, 500 007, India
3Department of Chemistry, P.G. College of Science, Saifabad, Hyderabad, India
*Corresponding Author
DOI No:

ABSTRACT:
A sensitive gas chromatography (GC)-mass spectrometry (MS) method is developed and validated for the determination of the residues p-Anisidine and 4-Methoxy-2-nitro aniline as genotoxic impurities in Esomeprazole magnesium drug substance.
KEYWORDS:
GC-MS, Esomeprazole, Selected ion monitoring.
Cite:
Yogeshwar Reddy M, Ramesh V, Kista Reddy Ch, Suryanarayana M.V, Dilip Kumar M, Raju G, Saravanan G, Debashish Datta. A Sensitive and Selective GC-MS Method for the Determination of Process Related Genotoxic Impurities in Esomeprazole Magnesium. Asian J. Research Chem. 3(2): April- June 2010; Page 395-397.
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