复元胶囊中山茱萸含量测定方法的探讨

Determination of Fructus Corni in Fuyuan Capsule

建立复元胶囊中山茱萸的含量测定方法。采用HPLC(高效液相色谱)法对复元胶囊中山茱萸主要成分莫诺苷(C_(17)H_(26)O_(11))和马钱苷(C_(17)H_(26)O_(10))进行含量测定;色谱柱Waters Symmetry■C_(18)柱(250 mm×4.6 mm,5μm),流动相为乙腈-0.3%磷酸溶液进行梯度洗脱,检测波长为240 nm。复元胶囊中山茱萸的两个被测组分的线性范围分别为:莫诺苷2.46~49.21μg/mL(r=0.9991)、马钱苷2.45~48.97μg/mL(r=0.9995);平均加样回收率分别为95.20%、93.42%,RSD分别为0.78%、0.93%(n=6);定量限分别为16.40,16.33 ng/mL;检测限分别为4.92、4.90 ng/mL;稳定性试验、重复性试验、精密度试验均良好,RSD均小于2.0%(n=6)。该方法操作简便、灵敏度高、准确可靠、稳定性和重复性良好,可作为复元胶囊的质量控制的方法。

To establish a method for determination of fructus corni in Fuyuan capsule.The content of morronoside(C_(17)H_(26)O_(11))and Loganin(C_(17)H_(26)O_(10))in fructus corni in Fuyuan capsules was determined by HPLC on Waters Symmetry■C_(18)column(250 mm×4.6 mm,5μm),and the High-performance liquid chromatography was determined by HPLC on Waters Symmetry C_(18)column(250 mm×4.6 mm,5μm),the mobile phase was acetonitrile-0.3%phosphoric acid solution,and the detection wavelength was 240 nm.The linear range of two components of Cornus officinalis in Fuyuan capsule was 2.46~49.21μg/mL(r=0.9991)and loganin 2.45~48.97μg/mL(r=0.9995),and the average recoveries were 95.20%and 93.42%,respectively,RSD was 0.78%and 0.93%(n=6),the quantitative limits were 16.40 and 16.33 ng/mL,and the detection limits were 4.92 and 4.90 ng/mL,respectively,RSD was less than 2.0%(n=6).The method is simple,sensitive,accurate,reliable,stable and repeatable,and can be used for the quality control of Fuyuan capsule.