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1 2013

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

Liu W.-Y., Xie Sh.-L., Xu X. Zh., Wu Ch. Y., Feng F.

Acta Chromatographica

2013

Vol. 25, no. 3

451--464

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).