Open AccessIsolation and Structural Characterization of Degradation Products of Aceclofenac by HPLC, HRMS and 2D NMR
Author(s) -
Santhosh Guduru,
V.V.S.R.N. Anji Karun Mutha,
B. Vijayabhaskar,
Muralidharan Kaliyaperumal,
Raghu Babu Korupolu,
Kishore Babu Bonige,
Chidananda Swamy Rumalla
Publication year - 2019
Publication title -
asian journal of chemistry/asian journal of chemistry
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.145
H-Index - 34
eISSN - 0975-427X
pISSN - 0970-7077
DOI - 10.14233/ajchem.2019.21798
Subject(s) - chemistry , degradation (telecommunications) , aceclofenac , high performance liquid chromatography , chromatography , stress (linguistics) , forced degradation , gradient elution , yield (engineering) , reversed phase chromatography , telecommunications , linguistics , philosophy , materials science , computer science , metallurgy
The stability of aceclofenac under stress conditions was assessed to identify the degradation products. So, it was subjected to stress conditions like acid, base and oxidation, according to ICH guideline Q1A (R2). One degradation product formed when the drug was subjected to acid stress. Three degradation products were formed during the basic stress condition. The drug substance was found to be stable to oxidative stress. The degradants formed during the stress were separated on a C-18 column using gradient preparative HPLC elution. The only product (DP-2) formed during the acid stress and this one is same as of one of the three degradation products (DP-1, DP-2, DP-3) were formed during base stress. 1D and 2D NMR spectra and mass spectral analysis supported the proposed structures for the products. The products DP-2 and DP-3 have been reported earlier but this is the first report of product DP-1 as a degradation product of aceclofenac.