Journal : Acta Chromatographica
Article : A study of impurities and degradation products in Oroxylin A by a validated liquid chromatographic method with analysis of their formation pathways

Authors :
Fatemi, M. H.
University of Mazandaran Laboratory of Chemometrics, Faculty of Chemistry Babolsar Iran, mhfatemi@umz.ac.ir,
Elyasi, M.
University of Mazandaran Laboratory of Chemometrics, Faculty of Chemistry Babolsar Iran,
Sowa, I.
Medical University of Lublin Department of Analytical Chemistry Chodźki 4a 20-093 Lublin Poland, i.sowa@umlub.pl,
Zajdel, D.
Medical University of Lublin Department of Analytical Chemistry Chodźki 4a 20-093 Lublin Poland,
Kocjan, R.
Medical University of Lublin Department of Analytical Chemistry Chodźki 4a 20-093 Lublin Poland,
Pizoń, M.
Medical University of Lublin Department of Analytical Chemistry Chodźki 4a 20-093 Lublin Poland,
Wójciak-Kosior, M.
Medical University of Lublin Department of Analytical Chemistry Chodźki 4a 20-093 Lublin Poland,
Hadad, G. M.
Suez Canal University Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy Ismailia 41522 Egypt, ghhadad@hotmail.com,
Abdel-Salam, R. A.
Suez Canal University Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy Ismailia 41522 Egypt, dr_rasalam@yahoo.com,
Abdel-Hameed, E. A.
Suez Canal University Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy Ismailia 41522 Egypt,
Liu, W.-Y.
China Pharmaceutical University Department of Pharmaceutical Analysis 24 Tongjiaxiang Nanjing 210009 China, liuwenyuan8506@163.com,
Xie, S.-L.
China Pharmaceutical University Department of Pharmaceutical Analysis 24 Tongjiaxiang Nanjing 210009 China,
Xu, X. Z.
China Pharmaceutical University Department of Pharmaceutical Analysis 24 Tongjiaxiang Nanjing 210009 China,
Wu, C. Y.
China Pharmaceutical University Department of Pharmaceutical Analysis 24 Tongjiaxiang Nanjing 210009 China,
Feng, F.
China Pharmaceutical University Department of Phytochemistry 24 Tongjiaxiang Nanjing 210009 China,
Abstract : Oroxylin A (5,7-dihydroxy-6-methoxyflavone), which has showed multiple pharmacological effects, was semi-synthesized chemically as a pharmaceutical agent. Its impurities, degradation products and their formation pathways remain unknown. In the present study, two impurities (5,6,7-trihydroxyflavone, 5-hydroxy-6,7-dimethoxytlavone) and a degradation product (5,7-dihydroxy-8-methoxyflavone) in Oroxylin A bulk drug substance were identified, and their formation pathways were proposed. A reversed phase liquid chromatographic method for the simultaneous determination of Oroxylin A and the three compounds was developed on a C18 column using methanol-acetonitrile-0.1% acetic acid (54:23:23, v/v/v) as the mobile phase. The detection was performed at 271 nm. The method was validated to be robust, precise, specific and linear between 4 and 40 μg mL-1; the limits of detection and quantification of Oroxylin A were 0.01 and 0.04 μg mL-1, respectively. The developed method was found to be suitable to check the quality of bulk samples of Oroxylin A at the time of batch release and also during its stability studies (long term and accelerated stability).

Keywords : oroxylin A, impurities and degradation products, simultaneous determination, RP-HPLC, formation pathways,
Publishing house : University of Silesia in Katowice
Publication date : 2013
Number : Vol. 25, no. 3
Page : 451 – 464

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DOI :
Qute : Fatemi, M. H. ,Elyasi, M. ,Sowa, I. ,Zajdel, D. ,Kocjan, R. ,Pizoń, M. ,Wójciak-Kosior, M. ,Hadad, G. M. ,Abdel-Salam, R. A. ,Abdel-Hameed, E. A. ,Liu, W.-Y. ,Xie, S.-L. ,Xu, X. Z. ,Wu, C. Y. ,Feng, F. ,Feng, F. , A study of impurities and degradation products in Oroxylin A by a validated liquid chromatographic method with analysis of their formation pathways. Acta Chromatographica Vol. 25, no. 3/2013
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