Technology for the determination of impurities in TRODAT-1 raw material

• Main Authors: HUANG CHIUNG FANG, HSIA YI CHIH, SU CHANG YUNG, FU YING KAI, LIU KUNG TIEN
• Format: Patent
• Language: English
• Published: 22.02.2007
• Subjects: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIRCHEMICAL OR PHYSICAL PROPERTIES; MEASURING; PHYSICS; TESTING

This invention discloses a novel technology for the impurities assay of TRODAT-1 raw material by reverse phase high performance liquid chromatography (RP-HPLC). The method for TRODAT-1 raw material impurities 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 resolution and raw material impurities. This invention is the first report in the world that proved the existence of oligomers in TRODAT-1 raw material, as well as an analytical method through elaborated validation procedures to quantify the impurities (including the oligomers) in TRODAT-1 raw material.