A new stability indicating HPLC and LC-APCI-MS methods for the estimation of Dacomitinib in pharmaceutical dosage forms

Abstract

Dacomitinib is an anti-cancer drug. A new stability indicating isocratic RP-HPLC and LC-APCI-MS methods have been developed and validated for the quantification of Dacomitinib as per ICH guidelines. Thermo scientific-TSQ Quantis with Vanquish HPLC coupled with MS was employed for the present study. Simpack C18 column was used for chromatographic resolution and a triple quadrupole mass spectrometer with atmospheric pressure chemical ionization (APCI) source, running in the positive mode (as well as negative mode) was used for detection. A wide linearity concentration range 2.0-200 μg/ml was shown by the proposed method. The m/z transitions were: 404.20 → 489.24. The proposed methods are simple, precise, accurate and used to quantify the marketed formulations of Dacomitinib.