METHODS FOR DETECTING AND REDUCING IMPURITIES OF LAPATINIB AND SALTS THEREOF

摘要

Impurities of lapatinib such as N-{3-chloro-4-[(2-fluorobenzyl)oxy]phenyl}-6-[5-({[2-(methylsulfonyl)ethyl]amino}methyl)furan-2-yl]quinazoline-4-amine compound of formula (I) or a salt thereof:;;and analytical methods for identifying and quantifying such impurities of Lapatinib and salts thereof are provided. Also provided is Lapatinib containing less than about 0.05 percent of this and related impurities and methods for preparing such pure forms of Lapatinib.

主权项

1. A method for detecting the compound of formula (I) in Lapatinib or a salt thereof comprising: a) adding a known amount of compound of formula (I) or a salt thereof to the Lapatinib sample or a salt thereof, b) carrying out HPLC analysis of the Lapatinib sample or a salt thereof of step a), and c) detecting the HPLC peak of the compound of formula (I).