HPLC测定口疮膜中靛蓝及靛玉红的含量

目的: 用HPLC法测定中药制剂口疮膜中靛蓝、靛玉红的含量。 方法: 采用Shim-pack CLC-ODS柱(6.0 mm×150 mm,5 μm),以甲醇-水(75:25)为流动相,流速1.0 mL·min^-1,柱温25℃,检测波长289 nm。 结果: 靛蓝浓度在1.1~21.0 μg·mL^-1范围内与峰面积线性关系良好(r=0.9998),平均加样回收率为104.5%(RSD=0.93%,n=5); 靛玉红在0.5~10.4 μg·mL^-1范围内与峰面积线性关系良好(r=0.9999),平均加样回收率99.0%(RSD=1.1%,n=5)。 结论: 本方法简便、准确、重现性好,可用于口疮膜的质量控制。

Objective: To establish an HPLC method for the content determination of indigo and indirubin in Kouchuang Mo. Methods: The contents of indigo and indirubin were determined by HPLC.The chromatographic column was Shim-pack CLC-ODS(6.0 mm×150 mm,5 μm),the mobile phase was methanol-water(75: 25) at a flow rate of 1.0 mL·min^-1 ,the temperature of column was 25℃ and the detection wavelength was 289 nm. Results: The linear relationship of indigo was ranged in 1.1-21.0 μg·mL^-1(r=0.9998) and the recovery was 104.5% with RSD of 0.93%(n=5).The linear corelation of the indimbin was in the range of 0.5~10.4 μg·mL^-1(r=0.9999) and the recovery was 99.0% with RSD of 1.1%(n=5). Conclusion: The method is simple,accurate and reproducible,which can be applied to the content determination of indigo and indirubin ,so as to ensure the stability of Kouchuang Mo.

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