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Vol. 31 No. 4 (2019): Vol 31 Issue 4

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Isolation and Structural Characterization of Degradation Products of Aceclofenac by HPLC, HRMS and 2D NMR

https://doi.org/10.14233/ajchem.2019.21798
Santhosh Guduru
Department of Medicinal Chemistry, GVK Biosciences Pvt. Ltd, IDA Mallapur, Hyderabad-500076, India; Department of Engineering Chemistry, Andhra University, Visakhapatnam-530003, India
V.V.S.R.N. Anji Karun Mutha
Department of Medicinal Chemistry, GVK Biosciences Pvt. Ltd, IDA Mallapur, Hyderabad-500076, India; Department of Engineering Chemistry, Andhra University, Visakhapatnam-530003, India
B. Vijayabhaskar
Department of Medicinal Chemistry, GVK Biosciences Pvt. Ltd, IDA Mallapur, Hyderabad-500076, India
Muralidharan Kaliyaperumal
Department of Medicinal Chemistry, GVK Biosciences Pvt. Ltd, IDA Mallapur, Hyderabad-500076, India
Raghu Babu Korupolu
Department of Engineering Chemistry, Andhra University, Visakhapatnam-530003, India
Kishore Babu Bonige
Department of Engineering Chemistry, Andhra University, Visakhapatnam-530003, India
Chidananda Swamy Rumalla
Department of Medicinal Chemistry, GVK Biosciences Pvt. Ltd, IDA Mallapur, Hyderabad-500076, India

Corresponding Author(s) : Chidananda Swamy Rumalla

chidanand_swamy@yahoo.co.in

Asian Journal of Chemistry, Vol. 31 No. 4 (2019): Vol 31 Issue 4

Abstract

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.

Keywords

Aceclofenac Degradation products
Guduru, S., Karun Mutha, V. A., Vijayabhaskar, B., Kaliyaperumal, M., Korupolu, R. B., Bonige, K. B., & Rumalla, C. S. (2019). Isolation and Structural Characterization of Degradation Products of Aceclofenac by HPLC, HRMS and 2D NMR. Asian Journal of Chemistry, 31(4), 851–854. https://doi.org/10.14233/ajchem.2019.21798
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