柴银口服液快速HPLC特征指纹图谱研究

Rapid HPLC Specific Fingerprint Chromatograms of Chaiyin Oral Solutions

目的:建立柴银口服液的快速HPLC特征指纹图谱,为质量控制与评价提供依据方法:对10批次柴银口服液进行分析。色谱柱:Purospher@STAR RP-18 endcapped(55 mm×4 mm,3μm);流动相:甲醇(A)-2%冰醋酸(B),梯度洗脱。检测波长:254 nm;流速:1.0 ml·min^(-1);柱温:30℃;进样量:10μl;运行时间:15 min。结果:采用《中药色谱指纹图谱相似废评价系统2.0版》进行分析,确定16个共有峰,精密度、稳定性和重复性试验结果均符合指纹图谱研究的要求,建立了柴银口服液的对照特征图谱,并进行相似度分析。结论:该法快速、简单、可靠,可以为现有柴银口服液的质量控制提供有益的补充。

Objective： To establish the specific chromatograms of Chaiyin oral solutions by rapid HPLC and provide evidence for the comprehensive quality control and evaluation. Methods： The samples were separated on a Purospher STAR RP-18 endcapped （55 mm ×4 mm,3 μm） column, the mobile phase consisted of methanol（A） and 2% glacial acetic acid（B） with a gradient elution program, the flow rate was 1.0 ml ·min^-1, the detection wavelength was set at 254 nm, the colunm temperature was 30℃, and the running time was 15 min. Resalts： All results of the experiment were analyzed with Chromatographic Fingerprint Evaluation System Version 2.0, and 16 common peaks were identified with promising precision, stability and repeatability. The standard specific chromat- ogram was established, and the similarity analysis was carried out. Conclusion： The method is rapid, simple and reliable, and can pro- vide helpful supplement for the quality control of Chaiyin oral solutions.