Article

Synthesis, characterization and identification of sertraline hydrochloride related impurities

Author : Nitin Bondre, Nitin Pradhan, Vihar Telange, Vishal Dashpute, Suryakant Pol, Sanjay Aher

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.


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