HPLC法测定复方罗布麻片中防己诺林碱与粉防己碱的含量

Determination of Fangchinoline and Tetrandrine in Compound Kendir Leaves Tablets by HPLC

目的用高效液相色谱(HPLC)法测定复方罗布麻片中防己诺林碱与粉防己碱的含量,控制药品中防己的含量。方法色谱柱为Hypersil ODS 2(5μm,4.6 mm×250 mm);流动相为乙腈-甲醇-水-冰醋酸(49∶23∶28∶1)(每100 ml含十二烷基硫酸钠0.41 g);流速为1.0 ml/min;检测波长为280 nm;柱温为35℃。进样量为10μl。以甲醇为溶剂超声30 min处理提取复方罗布麻片中防己诺林碱与粉防己碱。结果防己诺林碱在19.04～304.64μg/ml范围内线性关系良好,回归方程为y=7 758.4x-3.471 9(r=1.000 0,n=5),回收率为99.3%(n=6)。粉防己碱在16.16～258.56μg/ml范围内线性关系良好,回归方程为y=6 194.4x-0.238 4(r=1.000 0,n=5),回收率为99.4%(n=6)。结论该法能准确测定复方罗布麻片中防己诺林碱与粉防己碱的含量。

Objective To determine the content of Fangchinoline and Tetrandrine in Compound Kendir Leaves tablets by HPLC,And to control the content of the Stephaniae Tetrandrae Radix.Methods The Hypersil ODS 2 was used as the column（5 μm,4.6 mm×250 mm）.The mobile phase was acetonitrile-methanol-water-acetic acid（49∶23∶28∶1）（lauryl sodium sulfate 0.41 g/100 ml）.The flow rate was 1.0 ml/min.The detection wavelength was at 280nm.The column temperature was 35℃.The sample volume was 10 μl.Methyl alcohol was used as the solvent with ultrasound 30 min,Fangchinoline and Tetrandrine in Compound Kendir Leaves tablets was extracted.Results Fangchinoline showed a good linear relationship in the range of 19.04～304.64 μg/ml.the regression equation was y=7 758.4x-3.471 9（r=1.000 0,n=5）,The average recovery rate was 99.3%（n=6）.Tetrandrine showed a good linear relationship in the range of 16.16～258.56 μg/ml,the regression equation was y=6 194.4x-0.238 4（r=1.000 0,n=5）,the average recovery rate was 99.4%（n=6）.Conclusion The method is accurate,and can be used for the content determination of Fangchinoline and Tetrandrine in Compound Kendir Leaves tablets.