A novel technology for the purity assay of TRODAT-1 raw material

摘要

This invention discloses a novel technology for the purity assay of TRODAT-1 raw material by reverse phase high performance liquid chromatography (RP-HPLC). The method for TRODAT-1 raw material purity assay of this present invention includes using high performance liquid chromatography (HPLC), liquid chromatography tandem mass spectrometry (LC-MS/MS), HPLC column, preparation of samples, regents and eluent as well as performing parent and product ion analysis by mass spectrometry for the method validation, calculation of chromatographic resolutions and raw material purity. This invention discloses the first in the world of purity assay for TRODAT-1 raw material through elaborated validation procedures.