Abstract
The current study was undertaken to explore an innovative approach that employs liquid chromatography (LC) and liquid chromatography-mass spectrometry (LCMS/MS) for the resolution, identification, and characterization of minute quantities of degradation products (DPs) of abemaciclib, without the need for their isolation from reaction mixtures. This method successfully separated process-related impurities, including abemaciclib, on Zorbax XDB (250×4.6 mm; 5 μ id) C18 column at room temperature using 0.2 M phosphate buffer with pH4.2 and methanolin 80:20(v/v)asmobilephaseA,0.2M phosphate buffer with pH 4.2 and acetonitrile in the ratio of 30:70 (v/v) as mobile phase B. The mobile phase solvent A andBweremixedat50:50(v/v) and the mixture was pumped is ocratically at1.0mL/min and UV detection at 238 nm. The method demonstrates a sensitive detection limit of 0.09 μg/mL for the studied impurities, with a linear calibration curve spanning the range of 30 – 210 μg/mL for abemaciclib and 0.3 –