Quantification of Potential Genotoxic Impurities in Amlodipine Besylate Using an Agilent GC/Q-TOF System

Version 2

    Application Note

     

    Abstract

    This Application Note describes a GC/Q-TOF method for the determination of potential genotoxic impurities methylbenzene sulphonate (MBS) and ethylbenzene sulphonate (EBS) in amlodipine drug product. An Agilent 7890A GC coupled with an Agilent 7200A Series Q-TOF was used for the analysis. The unique design features of the Agilent Q-TOF enhances mass accuracy and mass resolution, which helps to confi rm the identity of trace impurities with high confi dence. An Agilent J&W DB-5ms column with helium as carrier gas was used to develop a 25-minute method to separate both analytes. The method was validated to evaluate the reproducibility analysis. Further MS/MS of EI spectra peaks was processed using Agilent MassHunter Molecular Structure Correlator (MSC) Software to elucidate the impurity structure by assigning substructures to fragments. The Agilent Q-TOF provided excellent sensitivity for the identifi cation and quantitation of these impurities without chemical derivatization.

     

    Publication number: 5991-6058EN.pdf

    Publication Date: August 1, 2015

     

    http://www.agilent.com/cs/library/applications/5991-6058EN.pdf