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.

The current research explains the stress degradation behavior of Apixaban, which is an anticoagulant or blood thinner. The degradation was conducted using hydrolytic, oxidative, thermal, and photolytic conditions. Apixaban is relatively stable in oxidative, thermal, and photolytic conditions; however, considerable degradation was observed in acid and base hydrolysis. Degradation products were identified using ultra-high performance liquid chromatographymass spectrometry, isolated using semi-preparative high-performance liquid chromatography, and structural characterization by high-resolution mass spectrometry and nuclear magnetic resonance spectroscopy. A total of five degradation products were identified and isolated in acid and base degradation. Degradation products 1, 2, and 3 were observed in acid conditions, whereas in base conditions, along with those three, two more degradation products 4 and 5 were identified. The representative thing was that among the five degradation products, two sets of positional isomers 1, 4, and 2, 5 were observed; out of which 2 and 5 are novel. The remaining degradation products 1, 3, and 4 are already reported tentatively using a single analytical technique of mass analysis without any evidence from nuclear magnetic resonance spectroscopy. Hence, the present study focused on using high-resolution mass, and nuclear magnetic resonance spectroscopy data for concrete confirmation of structures for degradation products.

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Idelalisib is a Quinazolinone derivative, phosphatidylinositol‐3‐kinase delta inhibitor that has been approved for the treatment of hematological malignancies. A liquid chromatography method was developed to study the degradation of Idelalisib. As per the International Conference on Harmonisation guidelines, Idelalisib was exposed to acid, base, oxidative, photolytic, and thermal degradation studies. Idelalisib was labile to acidic, basic, and oxidative stress conditions. It was stable in remaining conditions. Three degradation products were observed that were not yet reported in the literature. Degradation products are isolated by using preparative‐scale high‐pressure liquid chromatography apparatus with C18 column using gradient elution. Structural characterization done by using fragmentation pattern of high‐resolution mass spectroscopy and further confirmed by using extensive NMR spectroscopic studies. Degradation studies were performed to determine the intrinsic stability of a drug substance in formulation and to generate more stable formulation.