Asian Journal of Research in Chemistry

M. Yogeshwar Reddy ¹, V. Ramesh ², Ch. Kista Reddy ³, M. V. Suryanarayana ¹, M. Dilip Kumar ¹, G. Raju ², G. Saravanan ¹, Debashish Datta ¹

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

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.

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M. Yogeshwar Reddy ¹, V. Ramesh ², Ch. Kista Reddy ³, N. Venugopal ¹, G. Saravanan ¹, Y. Suresh ¹, M. Suryanarayana ¹, Debashish Datta ¹, B. Raju ²

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

Abstract

A Liquid chromatographic (LC) method using mass spectrometric (MS) detection was developed and validated for the trace analysis (ppm level) of 4-Bromo methyl-2'-Cyanobiphenyl in Valsartan drug substances. LC analysis of 4-Bromo methyl-2'-Cyanobiphenyl was done on Necleosil C18 (100 mm×4.6 mm, 3 μm) column and the mobile phase is in the ratio of 50:50:1 containing water, acetonitrile, and acetic acid. The flow rate was 1.0 mL min^-1 and the elution was monitored at 225 nm. The method was validated as per International Conference on Harmonization (ICH) guidelines. LC-MS is able to quantitate up to 1.0 ppm of 4-Bromo methyl-2'-cyanobiphenyl.

Keywords

Liquid Chromatography, Mass Spectrometry Valsartan.

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