高效液相色谱法测定肝力保胶囊中苦参碱及槐定碱的含量

High performance liquid chromatography in determination of matrine and sophoridine contents in Ganlibao capsule

目的建立高效液相色谱法测定肝力保胶囊中苦参碱及槐定碱含量。方法使用色谱柱Agilent NH2(4.6mm×250mm,5μm),流动相为1%磷酸无水乙醇乙腈=102268(V/V/V),流速0.8ml/min,柱温25℃,检测波长210nm。结果苦参碱在5.21～156.3μg/ml(r=1),槐定碱在5.29～158.7μg/ml(r=0.999 9)浓度范围内呈良好线性关系,其回归方程分别为Y=9.586 1 X+1.003 8和Y=7.604 3 X-5.920 1,回收率分别为98.73%(RSD=3.67%)、100.10%(RSD=2.24%)。15批肝力保胶囊中苦参碱含量为(30.13±0.19)～(44.70±0.17)mg/g,槐定碱含量为(21.60±0.25)～(52.07±0.11)mg/g。结论高效液相色谱法简便、准确,重复性好,可用于肝力保胶囊的进一步质量控制。

Objective To establish a high performance liquid chromatography approach for determining matrine and sophoridine contents in Ganlibao capsule.Methods Agilent NH2（4.6 mm×250 mm,5 μm） column was used with 1% phosphoric acidethanolacetonitrile（V/V/V=102268） as the mobile phase.The flow rate was 0.8 ml/min,and the temperature was at 25℃.The detection wavelength was set at 210 nm.Results The calibration curve of matrine showed a good linearity in the range of 5.21-156.3 μg/ml（r=1） and that of sophoridine in the range of 5.29-158.7 μg/ml（r=0.999 9）.The equations of linear regression of matrine and sophoridine were Y=9.586 1X＋1.003 8 and Y=7.604 3X-5.920 1,respectively.The recovery was 98.73%（RSD=3.67%） for matrine and 100.10%（RSD=2.24%） for sophoridine.The matrine content of 15 batches of Ganlibao capsule was（30.13±0.19）-（44.70±0.17） mg/g and the sophoridine content was（21.60±0.25）-（52.07±0.11） mg/g.Conclusion The present method is simple,accurate,and reproducible,and it can be used for the quality control of Ganlibao capsule.