Determination of Two Genotoxic Impurities Residues in Dronedarone Hydrochloride by HPLC-QTRAP-MS/MS

KeyWord:high performance liquid chromatography-quadrupole ion mass spectrometry£¨HPLC-QTRAP-MS/MS£©  potential genotoxic impuritie  dronedarone hydrochloride  residues

Abstract:

      A high performance liquid chromatography-quadrupole ion mass spectrometric£¨HPLC-QTRAP-MS/MS£© method was developed for the determination of two potential genotoxic impurities£¨impurity C and impurity D£© residues in dronedarone hydrochloride.After extracted with 0.1% formic acid-acetonitrile£¨20¡Ã80£©£¬the dronedarone hydrochloride samples were separated on an Agilent Extend-C18 column£¨1.8 ¦Ìm,2.1 mm¡Á50 mm£© or a YMC Pack-CN column£¨5 ¦Ìm,4ª±6 mm¡Á 250 mm£© with two mobile phases of 0.1% formic acid and acetonitrile.The detection of analytes was performed in the positive mode and selective reaction monitoring£¨SRM£© mode.As a result£¬the calibration curves of impurity C and impurity D showed good linearity in the range of 1.0-50 ¦Ìg/L.The limits of detection£¨S/N=3£© were 0.20 ¦Ìg/L and 0.30 ¦Ìg/L,respectively.The limits of quantitation£¨S/N=10£©were 0.80 ¦Ìg/L and 1.0 ¦Ìg/L£¬respectively.The method has the advantages of simple operation£¬high sensitivity£¬good reproducibility£¬and could be used for the detection of two genotoxic impurities residues in dronedarone hydrochloride.