A new stability indicating ultra-fast liquid chromatographic (RP-UFLC) method for the quantification of Nilotinib – A drug for blood cancer

Abstract

Nilotinib hydrochloride monohydrate is a tyrosine kinase inhibitor approved for the treatment of chronic myelogenous leukemia. A new stability indicating ultra-fast liquid chromatographic (RP-UFLC) method was developed for the quantification of Nilotinib and validated. Mobile phase consisting of a mixture of sodium acetate (pH 5.0): acetonitrile (40: 60, v/v) was used with flow rate 0.8 mL/min (UV detection at 254 nm) for the chromatographic study. Nilotinib obeys Beer-Lambert’s law over the concentration range of 0.2-80 μg/mL (R2 = 0.9999) with linear regression equation y = 175336x +20675. The LOQ was found to be 0.1897 μg/mL and the LOD was found to be 0.0619 μg/mL. Forced degradation studies were performed such as acidic, alkaline, oxidation and thermal degradations and the method was validated as per ICH guidelines.