公开(公告)号：US20070042501A1

公开(公告)日：2007-02-22

申请号：US11161883

申请日：2005-08-20

申请人： Kung Tien Liu ,  Yi Chih Hsia ,  Chung Yung Su ,  Chiung Fang Huang ,  Ying Kai Fu

发明人： Kung Tien Liu ,  Yi Chih Hsia ,  Chung Yung Su ,  Chiung Fang Huang ,  Ying Kai Fu

IPC分类号： G01N30/02

CPC分类号： G01N30/88 ,  G01N2030/8809 ,  Y10T436/25375

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.

摘要翻译： 本发明公开了通过反相高效液相色谱（RP-HPLC）对TRODAT-1原料的纯度测定的新技术。 本发明的TRODAT-1原料纯度测定方法包括使用高效液相色谱（HPLC），液相色谱串联质谱（LC-MS / MS），HPLC柱，样品制备，试剂和洗脱液以及 通过质谱法进行母体和产品离子分析，方法验证，色谱分辨率计算和原料纯度。 本发明通过详细的验证程序公开了TRODAT-1原料纯度测定世界第一。