Identification of reIated substances in ambrisentan by LC-MS MS techniques / 中国药科大学学报

ABSTRACT

An LC-TOF /MS and LC-MS /MS method was established for the identification the related substances in ambrisentan.HPLC separation was carried out on an XBridge C18 column(4.6 mm ×150 mm,3.5 μm)with linear gradient elution using a mobile phase consists of acetonitrile,water and 0.15% formic acid.The structures of the related substances were identified by electrospray positive ESI high resolution TOF /MS and MS /MS spec-tra,and verified further through reference substances.Ambrisentan and its related substances can be separated under the established HPLC conditions.Ten related substances were detected and identified.The established method is useful for the identification of related substances in ambrisentan.The results obtained are valuable for its manufacturing process optimization and quality control.