HPLC测定口疮膜中靛蓝及靛玉红的含量

Determination of indigo and indirubin in Kouchuang Mo by HPLC method

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,5μm),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1.1～21.0μg.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0.5～10.4μg.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 Kou- chuang Mo. Methods： The contents of indigo and indirubin were determined by HPLC. The chromatographic col- umn 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-l （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, accu- rate and reproducible, which can be applied to the content determination of indigo and indirubin , so as to ensure the stability of Kouchuang Mo.