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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

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          Summary

          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 C 18 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).

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          Author and article information

          Journal
          1326
          121093
          Acta Chromatographica
          A Sponsored Open Access Journal on Chromatography
          Acta Chromatographica
          Akadémiai Kiadó, co-published with Springer Science+Business Media B.V., Formerly Kluwer Academic Publishers B.V.
          1233-2356
          2083-5736
          1 September 2013
          : 25
          : 3
          : 451-464
          Affiliations
          [ 1 ] Department of Pharmaceutical Analysis, China Pharmaceutical University, 24 Tongjiaxiang, Nanjing, 210009, China
          [ 2 ] Key Laboratory of Drug Quality Control and Pharmacovigilance (China Pharmaceutical University), Ministry of Education, 24 Tongjiaxiang, Nanjing, 210009, China
          [ 3 ] Department of Phytochemistry, China Pharmaceutical University, 24 Tongjiaxiang, Nanjing, 210009, China
          Author notes
          Article
          4
          10.1556/AChrom.25.2013.3.4
          a8b65009-0242-4c53-84ba-cfa0cfa2188f

          Materials properties,Nanomaterials,Chemistry,Nanotechnology,Analytical chemistry,Thin films & surfaces
          simultaneous determination,oroxylin A,RP-HPLC,impurities and degradation products,formation pathways

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