Trace level quantification of 1-(3-chloropropyl)-4-(3-chlorophenyl)piperazine HCl genotoxic impurity in trazodone using LC–MS/MS

Abstract

A selective and sensitive liquid chromatography–tandem mass spectrometry (LC–MS/MS) method was developed for the quantitative determination of 1-(3-chloropropyl)-4-(3-chlorophenyl)piperazine HCl (CCP HCl) a process related impurity in trazodone. The method provided excellent sensitivity at a typical target analyte level of 0.9996. Limit of detection (LOD) and limit of quantification (LOQ) were found to be 0.01 and 0.03 ppm, respectively. The developed method was validated as per ICH guidelines in terms of LOD, LOQ, linearity, precision, accuracy, specificity and robustness. Keywords: LC–MS/MS, Linearity, Method development, Trazodone, Validation