HPLC法同时测定满山红疏肝颗粒中5种有效成分含量的研究

Research on the simultaneous determination of five active ingredients in Manshanhong Shugan granules by HPLC

  • 摘要: 目的:建立同时测定满山红疏肝颗粒中夏佛塔苷、田基黄苷、异槲皮苷、槲皮苷和原儿茶酸5种成分的含量的方法。方法:研究采用Agilent Zorbax SB-Aq-C18色谱柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.1%磷酸,梯度洗脱,体积流量0.8 mL/min,柱温30℃,检测波长为255 nm。结果:夏佛塔苷、田基黄苷、异槲皮苷、槲皮苷和原儿茶酸分别在浓度为0.097 6~1.171 2μg/mL、0.083 3~0.999 6μg/mL、0.046 9~0.562 8μg/mL、0.037 4~0.448 8μg/mL、0.011 0~0.132 0μg/mL范围内线性关系良好,有效成分在24 h内稳定性良好,重现性好,平均加样回收率分别为100.8%、100.8%,101.7%、101.3%、101.1%,RSD分别为1.1%、1.0%、0.7%、1.1%、1.3%。6批满山红疏肝颗粒中夏佛塔苷的含量在0.886 9~0.903 1 mg/g之间,田基黄苷的含量在0.191 7~0.203 4 mg/g之间,异槲皮苷的含量在0.082 7~0.105 2 mg/g之间,槲皮苷的含量在0.009 8~0.014 0 mg/g之间,原儿茶酸的含量在0.065 5~0.069 4 mg/g之间。结论:所建立的方法简便准确、专属性强、重现性好,为满山红疏肝颗粒建立了有效可行的质量控制体系。

     

    Abstract: Objective: To establish a method for the simultaneous determination of the contents of five components: schaftoside, vincetoxicoside B, isoquercitrin, quercitrin and protocatechuic acid in Manshanhong Shugan granules. Methods: The study employed an Agilent Zorbax SB-Aq-C18 chromatographic column(250 mm×4.6mm, 5 μm), with acetonitrile-0.1% phosphoric acid as the mobile phase, employing gradient elution at a volume flow rate of 0.8 mL/min, a column temperature of 30 ℃, and detection wavelength of 255 nm. Results: Schaftoside, vincetoxicoside B, isoquercitrin, quercitrin and protocatechuic acid exhibited good linear relationships within the concentration ranges of 0.0976 to 1.1712 μg/mL, 0.0833 to 0.9996 μg/mL, 0.0469 to 0.5628 μg/mL, 0.0374 to 0.4488 μg/mL, and 0.0110 to 0.1320 μg/mL, respectively. The active ingredients showed good stability within 24 hours, with good reproducibility. The average sample recovery rates were 100.8%, 100.8%, 101.7%, 101.3%,and 101.1%, respectively. The relative standard deviations(RSD) were 1.1%, 1.0%, 0.7%, 1.1%, and 1.3%, respectively. In six batches of Manshanhong Shugan granules, the content of schaftoside ranged from 0.8869 to 0.9031 mg/g, vincetoxicoside B ranged from 0.1917 to 0.2034 mg/g, isoquercitrin ranged from 0.0827 to 0.1052mg/g, quercitrin ranged from 0.0098 to 0.0140 mg/g, and protocatechuic acid ranged from 0.0655 to 0.0694 mg/g. Conclusion: The established method is simple, accurate, specific and reproducible, establishing an effective and feasible quality control system for Manshanhong Shugan granules.

     

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