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

• Autorzy: Liu W.-Y. , Xie Sh.-L. , Xu X. Zh. , Wu Ch. Y. , Feng F.
• Języki publikacji: EN

Abstrakty

EN

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).

Słowa kluczowe

EN

oroxylin A; impurities and degradation products; simultaneous determination; RP-HPLC; formation pathways

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2013
• Tom: Vol. 25, no. 3
• Strony: 451--464
• Opis fizyczny: Bibliogr. 15 poz., rys., tab.

Twórcy

autor

Liu W.-Y.

• China Pharmaceutical University Department of Pharmaceutical Analysis 24 Tongjiaxiang Nanjing 210009 China
• Ministry of Education Key Laboratory of Drug Quality Control and Pharmacovigilance (China Pharmaceutical University) 24 Tongjiaxiang Nanjing 210009 China

autor

Xie Sh.-L.

• China Pharmaceutical University Department of Pharmaceutical Analysis 24 Tongjiaxiang Nanjing 210009 China

autor

Xu X. Zh.

• China Pharmaceutical University Department of Pharmaceutical Analysis 24 Tongjiaxiang Nanjing 210009 China

autor

Wu Ch. Y.

• China Pharmaceutical University Department of Pharmaceutical Analysis 24 Tongjiaxiang Nanjing 210009 China
• Ministry of Education Key Laboratory of Drug Quality Control and Pharmacovigilance (China Pharmaceutical University) 24 Tongjiaxiang Nanjing 210009 China

autor

Feng F.

• China Pharmaceutical University Department of Phytochemistry 24 Tongjiaxiang Nanjing 210009 China

Bibliografia

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