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∶80),the dronedarone hydrochloride samples were separated on an Agilent Extend-C18 column(1.8 μm,2.1 mm×50 mm) or a YMC Pack-CN column(5 μm,46 mm× 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 μg/L.The limits of detection(S/N=3) were 0.20 μg/L and 0.30 μg/L,respectively.The limits of quantitation(S/N=10)were 0.80 μg/L and 1.0 μg/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.
关键词
高效液相色谱-四极杆/线性离子阱质谱仪基因毒性杂质盐酸决奈达隆残留
Keywords
high performance liquid chromatography-quadrupole ion mass spectrometry(HPLC-QTRAP-MS/MS)potential genotoxic impuritiedronedarone hydrochlorideresidues