Asian Journal of Research in Chemistry
  • Year: 2010
  • Volume: 3
  • Issue: 2

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

  • Author:
  • M Yogeshwar Reddy1,3,, V Ramesh2, Ch Kista Reddy3, M.V. Suryanarayana1, M Dilip Kumar1, G Raju2, G Saravanan1, Debashish Datta1
  • Total Page Count: 3
  • Page Number: 395 to 397

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 E-mail: yogeshwar.mamilla@matrixlabsindia.com

Online published on 13 March, 2013.

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