HPLC法测定板蓝根药材及制剂中靛蓝和靛玉红含量

HPLC determination of indigo and indirubin in Radix Isatidis and Banlangen granules

目的:建立高效液相色谱法测定板蓝根药材和板蓝根颗粒中靛蓝、靛玉红的含量。方法:采用Waters Symmetry-C18(250mm×4.6mm,5μm)色谱柱,流动相为甲醇-水(65∶35),流速1.0mL.min-1,检测波长285nm,柱温30℃;进样量10μL。结果:靛蓝、靛玉红线性范围分别为3.92～39.20μg·mL-1(r=0.9999)和2.36～23.60μg·mL-1(r=0.9996)。板蓝根药材中靛蓝、靛玉红平均加样回收率(n=5)分别为99.7%(RSD=2.1%)和104.3%(RSD=1.9%);板蓝根颗粒中靛蓝、靛玉红平均加样回收率(n=5)分别为99.7%(RSD=1.5%)和102.2%(RSD=2.1%),含量分别为6.57μg.g-1和含量为3.17μg.g-1。结论:该方法简便迅速,准确可靠,适用于板蓝根药材及其制剂的质量控制。

Objective：To establish an HPLC method for the determination of indigo and indirubin in Radix Isatidis and Banlangen granules.Methods：The chromatographic separation was performed on Waters Symmetry-C18（250 mm×4.6 mm,5 μm） column with column temperature of 30 ℃.The mobile phase consisted of methanol-water（65：35） at a flow rate of 1.0 mL·min-1.The detection wavelength was set at 285 nm,and the sample injection volume was 10 μL.Results：The calibration curves of indigo and indirubin were linear in the ranges of 3.92-39.20 μg·mL-1 （r=0.9999）and 2.36-23.60 μg·mL-1（r=0.9996）,respectively.In Radix Isatidis,the average recovery（n=5）of indigo and indirubin were 99.7%（RSD=2.1%）and 104.3%（RSD=1.9%）,respectively;In Banlangen granules,the average recovery（n=5）of indigo was 99.7%（RSD=1.5%）and the content was 6.57 μg·g-1,the average recovery of indirubin（n=5）was 102.2%（RSD=2.1%）and the content was 3.17 μg·g-1.Conclusion：The method is rapid and accurate,and it can be used for quality control of Radix Isatidis and Banlangen granules.