title: 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.
authors.affiliation: Analytical Research and Development, United States Pharmacopeial Convention-India (P) Ltd., Plot No. D6 & D8, IKP, Genome Valley, Shameerpet, Hyderabad,500078, India.
authors.forename: Ch Krishnam
authors.initials: CK
authors.lastname: Raju
authors.affiliation: Analytical Research and Development, United States Pharmacopeial Convention-India (P) Ltd., Plot No. D6 & D8, IKP, Genome Valley, Shameerpet, Hyderabad,500078, India.
authors.forename: Avadhesh Kumar
authors.initials: AK
authors.lastname: Pandey
authors.affiliation: Analytical Research and Development, United States Pharmacopeial Convention-India (P) Ltd., Plot No. D6 & D8, IKP, Genome Valley, Shameerpet, Hyderabad,500078, India.
authors.forename: Kaushik
authors.initials: K
authors.lastname: Ghosh
authors.affiliation: Analytical Research and Development, United States Pharmacopeial Convention-India (P) Ltd., Plot No. D6 & D8, IKP, Genome Valley, Shameerpet, Hyderabad,500078, India.
authors.forename: Arunima
authors.initials: A
authors.lastname: Pola
authors.affiliation: Analytical Research and Development, United States Pharmacopeial Convention-India (P) Ltd., Plot No. D6 & D8, IKP, Genome Valley, Shameerpet, Hyderabad,500078, India. Electronic address: skg@usp.org.
authors.forename: Sanath Kumar
authors.initials: SK
authors.lastname: Goud
authors.affiliation: Analytical Research and Development, United States Pharmacopeial Convention-India (P) Ltd., Plot No. D6 & D8, IKP, Genome Valley, Shameerpet, Hyderabad,500078, India.
authors.forename: Mrunal A
authors.initials: MA
authors.lastname: Jaywant
authors.affiliation: Analytical Research and Development, United States Pharmacopeial Convention-India (P) Ltd., Plot No. D6 & D8, IKP, Genome Valley, Shameerpet, Hyderabad,500078, India.
authors.forename: Sameer G
authors.initials: SG
authors.lastname: Navalgund
authors.affiliation: Analytical Research and Development, United States Pharmacopeial Convention-India (P) Ltd., Plot No. D6 & D8, IKP, Genome Valley, Shameerpet, Hyderabad,500078, India.
authors.forename: Koduru V
authors.initials: KV
authors.lastname: Surendranath
mesh_terms: D004340:Drug Contamination; D015394:Molecular Structure; D010080:Oxazoles / Q000737:chemistry* / Q000302:isolation & purification*; D010782:Photolysis; D011282:Pregnenediones / Q000737:chemistry* / Q000302:isolation & purification*
chemical_list: D010080:Oxazoles; D011282:Pregnenediones; C021988:deflazacort
keywords: Deflazacort; FTIR; NMR; Novel impurities; Q-TOF; UV degradation