International Journal of Drug Delivery Technology
Volume 14, Issue 4

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

Kaneriya V, Somaiya C*, Dholakia C, Dass R

Department of Chemical Science, Parul Institute of Applied Sciences, Parul University, Vadodara, Gujarat, 391760, India. 

Received: 17th Oct, 2024; Revised: 17th Nov, 2024; Accepted: 28th Nov, 2024; Available Online: 25th Dec, 2024 

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.

Keywords: GC, Trazodone Hydrochloride, Genotoxic impurity

How to cite this article: Kaneriya V, Somaiya C*, Dholakia C, Dass R. GC method development and validation of genotoxic impurity 1, 3 Dichloro propane, 3-chloro-1-bromopropane and 2 – Chloro pyridine content in Trazodone Hydrochloride API International Journal of Drug Delivery Technology. 2024;14(4):2054-59. doi: 10.25258/ijddt.14.4.16

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