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A novel reversed-phase liquid chromatography coupled with tandem mass spectrometric (LC-MS/MS) method was developed and validated for the trace analysis of ethyl 2-amino-4,5-bis(2methoxyethoxy)benzoate (ERL ethyl ester) and ethyl 4,5-bis(2-methoxyethoxy)-2-nitrobenzoate (ERL nitro compound) genotoxic impurities in Erlotinib Hydrochloride drug substance with the shorter run time. ERL ethyl ester and ERL nitro compound were identified as genotoxic impurities through DEREK nexus software. The method utilizes purosphere star RP 18 e (100 mm X 4.6 mm, 3.0 μm) column with electro spray ionization in multiple reaction monitoring (MRM) detection mode. The isocratic mode of elution for the impurities was carried out with the aid of the mobile phase using 0.1% formic acid in water & acetonitrile in the ratio of 42:58 v/v. The flow rate was 1.0 mL/min, column oven temperature 25oC and elution was monitored by mass spectrometer. The method was validated as per International Conference on Harmonization (ICH) guidelines and quantitate up to 1 ppm of ERL ethyl ester and ERL nitro compound.

oriental journal of chemistry/oriental journal of chemistry

A Selective and Sensitive Method Development and Validation by LC-MS/MS Approach for Trace Level Quantification of Potential Genotoxic Impurities of ERL Ethyl Ester and ERL Nitro Compound in Erlotinib Hydrochloride Drug Substance