决明退障口服液指纹图谱研究

Study on the Fingerprint of Jueming Tuizhang Oral Liquid

目的:建立了决明退障口服液的HPLC-DAD指纹图谱分析方法,确定了部分特征峰的归属。方法:采用HPLC法,Dikma Diamonsil C18色谱柱(250 mm×4.6 mm,5μm),以乙腈-0.1%醋酸水为流动相梯度洗脱,流速为1.0 m L/min,检测波长280 nm,柱温30℃,进样量10μL。结果:建立了10批决明退障口服液的指纹图谱,共有28个共有峰,多数峰分离度较好,具有较高的相似度。结论:建立的HPLC指纹图谱有较高的特征性和稳定性,为质量控制提供依据。

Objective： An HPLC - DAD fingerprint method for Jueming Tuizhang Oral Liquid was developed and some characteristic peaks were marked. Methods： A Dikma Diamonsil C18 column（250 mm ×4.6 mm, 5 μm） was used in HPLC, with acetonitrile -0. 1% acetic acid water as mobile phase, under the 280 nm detection wavelength. The column temperature was 30℃ with the flow rate of 1.0 mL/min, the sample volume was 10 μL. Results ： 10 batches of HPLC fingerprints were established. 28 common peaks were selected in all samples. Among the obtained fingerprints, most of the detected peaks were separated effectively. Conclusion： The established HPLC fingerprint has repeatability and stability, which provides quality control reference for Jueming Tuizhang Oral Liquid.