Stability-indicating assay method for acotiamide: Separation, identification and characterization of its hydroxylated and hydrolytic degradation products along with a process-related impurity by ultra-high-performance liquid chromatography/electrospray ionization quadrupole time-of-flight tandem mass spectrometry.

All the observed DPs were new and formed by hydrolysis of an amide bond, phenyl ring hydroxylation and hydrolysis of the methoxy group of the phenyl ring. The despropyl process-related impurity was observed and well separated from the drug. The proposed UHPLC mass spectrometric method has greater utility in the identification of DPs in much less time with excellent selectivity.