Abstract:
:Forced Degradation of Deflazacort drug substance in ultraviolet light condition resulted into a number of significant degradation products. Two of these degradation products were found to be unknown during the study and marked as DD-I and DD-II. Thus, the objective of this work is to investigate and identify these two novel degradation products of DFZ. The isolation method for these new degradation products were developed using a new reverse-phase high performance liquid chromatography (HPLC). DD-I and DD-II, eluting at 0.53 and 1.57 relative retention times with respect to Deflazacort (DFZ) peak respectively, were isolated from reaction mass using preparative HPLC and their structures were elucidated using high resolution MS, multidimensional NMR and FTIR spectroscopic techniques. To best of our knowledge, these two degradation products are novel impurities which are not discussed in any form of publication yet.
journal_name
J Pharm Biomed Analjournal_title
Journal of pharmaceutical and biomedical analysisauthors
Raju CK,Pandey AK,Ghosh K,Pola A,Goud SK,Jaywant MA,Navalgund SG,Surendranath KVdoi
10.1016/j.jpba.2016.11.005subject
Has Abstractpub_date
2017-01-30 00:00:00pages
82-89eissn
0731-7085issn
1873-264Xpii
S0731-7085(16)31054-8journal_volume
133pub_type
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