Isolation and structural characterization of novel photolytic degradation impurities of Deflazacort using Q-TOF, 2D-NMR and FTIR.

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 Anal

authors

Raju CK,Pandey AK,Ghosh K,Pola A,Goud SK,Jaywant MA,Navalgund SG,Surendranath KV

doi

10.1016/j.jpba.2016.11.005

subject

Has Abstract

pub_date

2017-01-30 00:00:00

pages

82-89

eissn

0731-7085

issn

1873-264X

pii

S0731-7085(16)31054-8

journal_volume

133

pub_type

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