Isolation, identification and characterization of new degradation products of Carfilzomib using high resolution mass spectrometry and nuclear magnetic resonance

Carfilzomib is a newly approved tetra peptide epoxy ketone proteasome inhibiting agent for relapsed or refractory multiple myeloma. Very few stability studies are available on this drug. Carfilzomib (CFZ) is subjected to forced degradation under neutral, acid, base, oxidative, thermal and photolytic stress conditions as per ICH guidelines which results in formation of six degradation products in base hydrolysis. Out of six, four degradation products are reported in literature. UPLC method has been developed for separation of degradation products from CFZ drug. DP-1 and DP-2 which are novel degradants structurally elucidated by high resolution mass spectrometry and nuclear magnetic resonance.