通窍耳聋丸UPLC特征图谱的研究

Study on Specific Chromatogram of Tongqiao Erlong Pills by UPLC

目的:用UPLC建立通窍耳聋丸特征图谱的质量评价方法。方法:Acquity UPLC BEH C_(18)色谱柱(2.1 mm×100 mm,1.7μm);流动相为甲醇-0.1%磷酸溶液,采用梯度洗脱;流量0.3 mL·min^(-1);检测波长250 nm;柱温35℃。结果:建立的特征图谱信息丰富,7味中药材中的15个特征峰分离良好,且重复性和稳定性的相对标准偏差均小于1.0%。结论:所建立的方法快速、可靠,专属性强,适用于全面控制通窍耳聋丸的质量。

Objective ： To establish an UPLC method of specific chromatogram for the quality evaluation of Tongqiao Erlong Pills. Meth- otis ： The separation was performed on an Acquity UPLC BEH CIs column （2. 1 mm × 100 mm, 1.7 μm）, the mobile phase was a mixture of methanol-0. 1% phosphoric acid at a flow rate of 0. 3 mL · min^- 1, gradient elution. The wavelength was set at 250 nm and the temper- ature of the column was 35 ℃. Results： The information of UPLC specific chromatogram was very abundant, 15 components of 7 Chinese herbal medicines could be separated completely, and the RSDs of repeatability and stability were less than 1.0%. Conclusion： The method is fast, simple and reliable, which can be used for the comprehensive quality control of Tongqiao Erlong Pills.