Asian Journal of Research in Chemistry

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


Affiliations
1 Matrix Laboratories Ltd., R and D Centre, Jinnaram Mandal, Medak-502325, India
2 National Centre for Mass Spectrometry, Indian Institute of Chemical Technology, Hyderabad-500007, India
3 Department of Chemistry, P.G. College of Science, Saifabad, Hyderabad, India
     

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

Abstract Views: 217  |  PDF Views: 0

Authors

M. Yogeshwar Reddy
Matrix Laboratories Ltd., R and D Centre, Jinnaram Mandal, Medak-502325, India
V. Ramesh
National Centre for Mass Spectrometry, Indian Institute of Chemical Technology, Hyderabad-500007, India
Ch. Kista Reddy
Department of Chemistry, P.G. College of Science, Saifabad, Hyderabad, India
M. V. Suryanarayana
Matrix Laboratories Ltd., R and D Centre, Jinnaram Mandal, Medak-502325, India
M. Dilip Kumar
Matrix Laboratories Ltd., R and D Centre, Jinnaram Mandal, Medak-502325, India
G. Raju
National Centre for Mass Spectrometry, Indian Institute of Chemical Technology, Hyderabad-500007, India
G. Saravanan
Matrix Laboratories Ltd., R and D Centre, Jinnaram Mandal, Medak-502325, India
Debashish Datta
Matrix Laboratories Ltd., R and D Centre, Jinnaram Mandal, Medak-502325, India

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.