Journal :   Asian Journal of Research in Chemistry

Volume No. :   4

Issue No. :  6

Year :  2011

Pages :   898-901

ISSN Print :  0974-4169

ISSN Online :  0974-4150


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The Quantitative Determination of Process Related Genotoxic Impurities in Esomeprazole Magnesium by GC-MS



Address:   M. Yogeshwar Reddy1,3*, V. Ramesh2, Ch. Kista Reddy3, N. Venugopal1, G. Saravanana1, M.V. Suryanarayana1, B. Shyam Sunder 1, R.Surendranath Reddy1 and G. Raju2
1Matrix Laboratoires Ltd., R&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-mass spectrometric (GC-MS) method is developed and validated for the determination of residuals 2-Chloromethyl-4-methoxy-3,5-dimethyl pyridine HCl (2), 2,3,5-Trimethyl pyridine N-oxide (3), 4-Nitro-2,3,5-Trimethyl pyridine N-oxide (4) and 4-Methoxy-2,3,5-Trimethyl pyridine N-oxide (5) are genotoxic impurities in Esomeprazole magnesium (1) drug substance. Under the optimal conditions, the recovery for 2, 3, 4, and 5 are between 109.4% to 116.8%, 99.9% to 107.6%, 96.0% to 104.1%, and 87.4% to 105.2% for spiked samples at limits of quantification (LOQ) level in sample preparation. Limits of quantification (LOQ) and detection (LOD) are about 5 ppm and 1.5 ppm for the standard solutions of 2, 3, 4, and 5. The linearity values are 0.9989, 0.9968, 0.9988, and 0.9999 for 2, 3, 4, and 5. Based on these results, the method is applied to determine the residual genotoxic impurities are, 2-Chloro methyl-4-methoxy-3,5-dimethyl pyridine HCl (2), 2,3,5-Trimethyl pyridine N-oxide (3), 4-Nitro-2,3,5-Trimethyl pyridine N-oxide (4) and 4-Methoxy-2,3,5-Trimethyl pyridine N-oxide (5) in Esomeprazole magnesium (1) drug substance.
KEYWORDS:
Esomeprazole magnesium, Single ion monitoring, Gas chromatography-Mass spectrometry.
Cite:
M. Yogeshwar Reddy, V. Ramesh, Ch. Kista Reddy, N. Venugopal, G. Saravanana, M.V. Suryanarayana, B. Shyam Sunder , R.Surendranath Reddy, G. Raju. The Quantitative Determination of Process Related Genotoxic Impurities in Esomeprazole Magnesium by GC-MS. Asian J. Research Chem. 4(6): June, 2011; Page 898-901.
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