三勒浆口服液HPLC指纹图谱的建立及多成分定量测定

HPLC fingerprint of Sanlejiang Oral Liquid and content determination of multi-components

目的建立三勒浆口服液(SOL)的HPLC指纹图谱,测定其中主要成分量,为SOL的质量控制提供参考。方法采用Welchrom C18色谱柱(250 mm×4.6 mm,5μm),以0.1%磷酸水溶液-甲醇为流动相进行梯度洗脱,体积流量为1.0 m L/min,检测波长270 nm,柱温25℃,建立SOL的HPLC指纹图谱,并对没食子酸、没食子儿茶素、表儿茶素、柯里拉京和鞣花酸指标成分的定量测定进行方法学考察。结果在SOL特征指纹图谱研究中,共确定22个共有峰,同时利用相似度软件对10批SOL指纹图谱进行分析,各批次样品相似度在0.95以上;通过对比特征峰的保留时间,指认出5种主要成分,分别为没食子酸(3号峰)、没食子儿茶素(8号峰)、表儿茶素(15号峰)、柯里拉京(16号峰)和鞣花酸(21号峰);并且10批样品中没食子酸的量在5.743 2~7.538 0 mg/m L,没食子儿茶素的量在0.492 9~0.847 1 mg/m L,表儿茶素的量在0.529 7~0.8048 mg/m L,柯里拉京的量在0.937 5~1.756 5 mg/m L,鞣花酸的量在0.352 7~0.554 5 mg/m L。结论所建立的SOL HPLC指纹图谱和定量测定方法简单,分离效果较好,重复性好,实现了对SOL定性和定量的双重研究,可为其质量控制提供参考。

Objective To establish an HPLC fingerprint method of Sanlejiang Oral Liquid（SOL） and determine the contents of its main components, combining with clustering analysis for quality consistency evaluation of different batches, so as to provide a reference for the quality control. Methods Welchrom C18（250 mm × 4.6 mm, 5 μm） column was adopted, the mobile phase consisted of 0.1% phosphoric acid water-methanol with gradient elution at the flow rate of 1.0 m L/min, and the detection wavelength was 270 nm, the column temperature was 25 ℃. HPLC fingerprint of SOL was established and determination method of gallic acid, gallocatechin, epicatechin, corilagin, and ellagic acid were studied methodologically. Results The fingerprint chromatography included 22 mutual peaks. At the same time, the 10 batches of SOL fingerprints were analyzed by similarity software, the similarity among the batches was more than 0.95. Based on the tetention time of master compounds, five components [gallic acid（peak 3）, gallocatechin（peak 8）, epicatechin（peak 15）, corilagin（peak 16）, and ellagic acid（peak 21）] were identified and quantified. The contents of gallic acid, gallocatechin, epicatechin, corilagin, and ellagic acid in 10 batches of Sanlejiang Oral Liquid were 5.743 2—7.538 0, 0.492 9—0.847 1, 0.529 7—0.804 8, 0.937 5—1.756 5, and 0.352 7—0.554 5 mg/m L, respectively. Conclusion The established method is simple in good separation and reproducibility, achieving the qualitative and quantitative research for SOL, and thus can provide a reference for the standard and evaluation of quality of SOL.