GC method development and validation of genotoxic impurity 1, 3 Dichloro propane, 3-chloro-1-bromopropane and 2Chloro pyridine content in Trazodone Hydrochloride API

Trazodone is often used to treat major depression. A50 - 300 mg tablet formulation thatcontains1, 3 Dichloro propane, 3-chloro-1-bromopropane, and 2-Chloro pyridine as a genotoxic impurity. In the present study, the GC method is effectively developed and validated under the required regulations. This method is established for the quantification of 1, 3 Dichloro propane, 3-chloro-1-bromopropane, and 2 – Chloro pyridine in Trazodone hydrochloride API.The sample preparation method is easy and free of toxic solvents. The method demonstrated excellent linearity over a concentration range of 0.3 μg/ml to 2 μg/ml. The method was highly précised and robust. The proposed GC method holds promise for both qualitative and quantitative analyses of 1, 3 Dichloro propane, 3-chloro-1-bromopropane and 2-Chloro pyridine in Trazodone hydrochloride formulations.