Rapid oligonucleotide drug impurity determination by direct spectral comparison of ion-pair reversed-phase high-performance liquid chromatography electrospray ionization mass spectrometry data

摘要

RationaleQuantitative ion-pair (IP) high-performance liquid chromatography/mass spectrometry (HPLC/MS) methods are employed to determine the complex impurity profiles of oligonucleotide therapeutics. While impurities that co-elute with the main product are routinely monitored, the large number of early and late eluting impurities makes their individual measurements tedious and time-consuming. An improved method is needed for routine analyses.