基于一测多评法的肝舒胶囊中7种成分含量测定

Determination of seven components in Ganshu capsules based on quantitative analysis of multi-components by single-marker

  • 摘要: 目的:基于一测多评法(QAMS)建立肝舒胶囊中虎杖苷、新绿原酸、绿原酸、隐绿原酸、异绿原酸A、异绿原酸B、异绿原酸C 7种成分含量测定方法。方法:采用HPLC法,Phenomenex NX-C18柱(250 mm×4.6 mm×5 μm),乙腈—0.2%甲酸水溶液为流动相,梯度洗脱,流速为1.00 mL/min,检测波长328 nm,以虎杖苷为内参物,建立该成分与其他6个成分的相对校正因子,计算各成分含量,并与外标法测定所得含量进行比较,验证所建立方法的可行性。结果:新绿原酸、绿原酸、隐绿原酸、异绿原酸B、异绿原酸A、异绿原酸C 的相对校正因子(RCF)分别为1.192 2、1.183 9、1.278 9、1.051 0、0.994 7、0.994 5,相对保留时间(RRT)分别为0.304 2、0.503 6、0.551 3、1.153 1、1.193 1、1.277 1。5批样品QAMS计算所得结果与外标法检测结果一致(相对误差在-5%~5%)。结论:建立的QAMS操作简便,稳定性、精密度与重复性均良好,可用于肝舒胶囊的质量控制。

     

    Abstract: Objective: To determine seven components in Ganshu capsules, namely, polydatin, neochlorogenic acid, chlorogenic acid, cryptochlorogenic acid, isochlorogenic acid A, isochlorogenic acid B, and isochlorogenic acid C based on quantitative analysis of multi-components by single-marker (QAMS).Methods: High perfor-mance liquid chromatography (HPLC) was used with a Phenomenex NX-C18(250 mm×4.6 mm×5 μm) column, acetonitrile-water (0.2% formic acid solution) was as mobile phase with gradient elution at the flow rate of 1.00 mL/min, and the detection wavelengths were 328 nm.With polydatin as the internal reference, the relative correc-tion factor of this component and the other six components were established, the contents of each component were calculated, and the contents determined by the external standard method were compared to verify the feasi-bility of the established method.Results: The relative correction factor(RCF)of neochlorogenic acid, chlorogen-ic acid,cryptochlorogenic acid, isochlorogenic acid B, isochlorogenic acid A, isochlorogenic acid C was 1.192 2, 1.183 9, 1.278 9, 1.051 0, 0.994 7 and 0.994 5, respectively, and their relative retention time(RRT)was 0.304 2, 0.503 6, 0.551 3, 1.153 1, 1.193 1 and 1.277 1, respectively.The results calculated by QAMS method for 5 batch-es of samples were consistent with the results measured by external standard method (the relative error is-5%-5%).Conclusion: The QAMS method is simple with good stability, precision and repeatability, and can be used for quality control of Ganshu capsules.

     

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