Synthesis, characterization and identification of sertraline hydrochloride related impurities

Abstract

Sertraline hydrochloride is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class, is synthesized for commercial use as a drug substance in highly pure form. During commercial production of Sertraline Hydrochloride, two unknown impurities were detected in final API at levels ranging from 0.05% to 0.15% in gas chromatography (GC) analysis. For regulatory compliances, it was mandatory to identify these two unknown impurities. In present work these two impurities are identified, synthesized and characterized as 1-(3,4-Dichlorophenyl)-1,2,3,4-tetrahydronaphthalene and 1-(3,4-Dichlorophenyl)-1,2-dihydronaphthalene.