GC method development and validation of genotoxic impurity 1, 3 Dichloro propane, 3-chloro-1-bromopropane and 2Chloro pyridine content in Trazodone Hydrochloride API
Year: 2024
Type: article
Abstract: 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.
Authors: Kaneriya V, Somaiya C, Dholakia C, Dass R
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: hybrid
OpenAlex ID: W4405926199