双山颗粒剂HPLC指纹图谱研究

Studies on HPLC Fingerprint of Shuangshan Granules

摘要:

目的: 建立双山颗粒HPLC指纹图谱分析方法,科学评价并有效控制双山颗粒剂质量。 方法: 采用反相高效液相色谱法,色谱柱为Diamonsil C₁₈柱 (4.6 mm×250 mm,5 μm),乙腈-0.1%磷酸溶液梯度洗脱,流速1.0 mL·min^-1,检测波长340 nm,柱温25 ℃。 结果: 以绿原酸为参照峰,建立了双山颗粒剂HPLC指纹图谱,确立了13个共有峰,供试品之间的共有峰相似度>0.98。 结论: 该方法准确,精密度、重复性较好,可作为控制双山颗粒质量的依据。

Abstract:

Objective:HPLC chromatographic fingerprints for Shuangshan granules were developed in order to evaluate the internal quality. Method: HPLC analysis was performed at 25 ℃ by using a Diamonsil C₁₈ column (4.6 mm×250 mm,5 μm), with the gradient elute of mobile phase consisting of acetonitrile-0.1% glacial acetic acid at the flow rate of 1.0 mL·min^-1. The UV detection was set at 340 nm. Result: Chlorogenic acid was used as the reference substance in the HPLC chromatographic fingerprint of Shuangshan Granules, which showed 13 common peaks and the similarity was 0.98 among 10 samples. Conclusion: This method was accurate, repeatable and useful for the quality control of Shuangshan granules.