1 research outputs found
Identification and Characterization of Potential Impurities of Dronedarone Hydrochloride
Six
potential process related impurities were detected during the
impurity profile study of an antiarrhythmic drug substance, Dronedarone
(<b>1</b>). Simple high performance liquid chromatography and
liquid chromatography–mass spectrometry methods were used for
the detection of these process impurities. Based on the synthesis
and spectral data (MS, IR, <sup>1</sup>H NMR, <sup>13</sup>C NMR,
and DEPT), the structures of these impurities were characterized as
5-amino-3-[4-(3-di-<i>n</i>-butylaminopropoxy)benzoyl]-2-<i>n</i>-butylbenzofuran (impurity I); <i>N</i>-(2-butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)benzofuran-5-yl)-<i>N</i>-(methylsulfonyl)methanesulfonamide (impurity II); <i>N</i>-(2-butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)benzofuran-5-yl)-1-chloromethanesulfonamide
(impurity III); <i>N</i>-{2-propyl-3-[4-(3-dibutylaminopropoxy)benzoyl]benzofuran-5-yl}methanesulfonamide
(impurity IV); <i>N</i>-(2-butyl-3-(4-(3-(dibutylamino)propoxy)benzoyl)benzofuran-5-yl)formamide
(impurity V); and (2-butyl-5-((3-(dibutylamino)propyl)amino)benzofuran-3-yl)(4-(3-(dibutylamino)propoxy)phenyl)methanone
(impurity VI). The synthesis and characterization of these impurities
are discussed in detail