Determination of N-Methyl-o-phenylenediamine in Telmisartan by HPLC-QTRAP-MS/MS

KeyWord:high performance liquid chromatography-quadrupole ion mass spectrometry£¨HPLC-QTRAP-MS/MS£©  N-methyl-o-phenylenediamine  telmisartan

Abstract:

      A high performance liquid chromatography-quadrupole ion mass spectrometric£¨HPLC-QTRAP-MS/MS£© method was developed for the determination of N-Methyl-o-phenylenediamine residues in telmisartan.After extracted with water-acetonitrile£¨80¡Ã20£¬by volume£©£¬the telmisartan samples were separated on an Agilent Eclipse XDB-C18 column£¨3.5 ¦Ìm,2.1 mm¡Á100 mm£© with a mobile phase of 0.1% formic acid solution-acetonitrile.The electrospray was operated in the positive mode and the samples were monitored under the select reaction monitoring£¨SRM£© mode.As a result£¬the calibration curves of N-Methyl-o-phenylenediamine showed a good linearity£¨r>0.99£© in the range of 2.0-50 ¦Ìg/L.The limits of detection£¨S/N=3£© was 0.5 ¦Ìg/L £¬and the limits of quantitation£¨S/N=10£© was 2.0 ¦Ìg/L.The method has the advantages of simple operation£¬high sensitivity£¬good reproducibility£¬and could be used for the detection of N-Methyl-o-phenylenediamine residues in telmisartan.