1Matrix Laboratories Ltd., R and D centre, Jinnaram Mandal, Medak, 502325, India
3Department of Chemistry, P.G. College of Science, Saifabad, Hyderabad, India
2National Centre for Mass Spectrometry, Indian Institute of Chemical Technology, Hyderabad, 500 007, India
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 x 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.
Liquid chromatography, mass spectrometry Valsartan