高效液相色谱法同时测定独一味分散片中两种活性成分的含量

Simultaneous Determination of Two Active Components in Lamiophlomis Rotata Dispersible Tablets by HPLC

目的:建立同时测定独一味分散片中2种活性成分的高效液相色谱分析方法。方法:采用Waters XBridge C18(4.6 mm×250 mm,5μm)色谱柱,以乙腈(A)-水(B)为流动相,梯度洗脱(0~11 min,9%A;11~14 min,9%A→15%A;14~35 min,15%A),流速:1.0 m L/min,检测波长为235 nm,柱温:30℃,样品采用70%甲醇回流提取。结果:山栀苷甲酯在0.034 56~0.691 3μg之间线性关系良好,r2=0.999 6,平均回收率为99.33%,RSD=0.56%。8-O-乙酰山栀苷甲酯在0.077 92~1.558 4μg之间线性关系良好,r2=0.999 8,平均回收率为99.20%,RSD=0.70%。结论:该方法操作简单,重复性好,准确度高,分离效果好,可以用于独一味分散片的质量控制。

Objective： To establish a method for simultaneous determination of two active components in Lamiophlomis rotata dispersible by HPLC. Methods： The Waters XBridge C18（4. 6 mm × 250 mm,5 μm） column was used,the mobile phase was acetonitrile（A）-water（B） as a gradient mode（A： 0 - 11 min,9%; 11 - 14 min,9%→15%; 14 - 35 min,15%）,the flow rate was 1. 0 m L/min,the detection wavelength was 235 nm,the column temperature was 30 ℃,and the sample was extracted with 70% methanol by reflowing. Results： The concentration of Shanzhiside methyl ester showed a good liner relationship in the range of 0. 03456 - 0. 691 3 μg,r^2=0. 999 6,and the average recvery was 99. 33%,RSD = 0. 56%. The concentration of 8-O-acetyl shanzhiside methyl ester showed a good liner relationship in the range of 0. 077 92 - 1. 558 4 μg,r^2= 0. 999 8,and the average recovery was 99. 20%,RSD = 0. 70%. Conclusion： This method is simple,has good repeatability and high accuracy,good separation effect,and can be used for the quality control of Lamiophlomis rotata dispersible tablets.