Asian Journal of Research in Chemistry

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Low-Level Determination of Residual 4-Bromo Methyl-2'-Cyanobiphenyl in Valsartan by Liquid Chromatography-Mass Spectrometry


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 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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  • Low-Level Determination of Residual 4-Bromo Methyl-2'-Cyanobiphenyl in Valsartan by Liquid Chromatography-Mass Spectrometry

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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
N. Venugopal
Matrix Laboratories Ltd., R and D Centre, Jinnaram Mandal, Medak-502325, India
G. Saravanan
Matrix Laboratories Ltd., R and D Centre, Jinnaram Mandal, Medak-502325, India
Y. Suresh
Matrix Laboratories Ltd., R and D Centre, Jinnaram Mandal, Medak-502325, India
M. Suryanarayana
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
B. Raju
National Centre for Mass Spectrometry, Indian Institute of Chemical Technology, Hyderabad-500007, India

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.