Author(s)

Arun Bhutnar^*, Sachin Khapare, Anita Desai, Smitha Dsouza

Formulation Analytical Development Laboratory (FD ADL), Integrated Project Development (IPD), Cipla Ltd., Mumbai, India.

Budesonide is a corticosteroid used for the treatment of asthma via various matrices and inhalation mechanisms. An unknown peak of Budesonide aqueous formulation has been investigated during stability study wherein the impurity level observed around 0.1% well below the threshold 0.5%. The approach to identify anonymous species was adopted as first to generate the impurity in sample, isolate, enrich and was subjected to LC-MS/MS and NMR for spectral studies. Based on the spectral data the anonymous species were identified as a “Lumibudesonide’’ ((5aR,5bS,5cS,6S,7aS,7bS,10aR,11aS,11bS)-6-hydroxy-7b-(2-hydroxyacetyl)-5b,7a-dimethyl-9-propyl 1,5a,5b,5c,6,7,7a,7b,10a,11,11a,11b dodecahydrocyclopenta[2'',3'']cyclopropa [1'',2'':3', 4']benzo [1',2':4,5]indeno [1,2-d][1,3]dioxol-5(2H)-one), which is observed in photolysis of Budesonide.

Budesonide, Lumibudesonide, Photodegradation, LC-MS/MS, NMR, Degradation Study

Bhutnar, A. , Khapare, S. , Desai, A. and Dsouza, S. (2017) Isolation and Characterization of Photodegradation Impurity in Budesonide Drug Product Using LC-MS and NMR Spectroscopy. American Journal of Analytical Chemistry, 8, 449-461. doi: 10.4236/ajac.2017.87034.