前列安栓高效液相色谱指纹图谱质量控制方法研究

HPLC fingerprint for quality control of Qianlie'an suppository

目的建立前列安栓HPLC指纹图谱质量控制方法。方法采用HPLC法,以AgilentHC-C18(250mm×4.6mm,5μm)为色谱柱,甲醇-0.25%冰醋酸为流动相二元梯度洗脱,流速1.0 mL min-1,检测波长280nm,柱温:25℃,进样量10μL,采集时间90 min。结果通过方法学考察建立了前列安栓HPLC指纹图谱,并对12批样品进行了指纹图谱检测分析,共检出共有峰26个,12批样品的相似度均>0.90,相似度良好。结论该法具有可操作性,可有效控制样品质量。

Objective To establish the HPLC fingerprint for the quality control of Qianlie＇an suppository. Methods HPLC fingerprint was established with Agilent HC-C18 （250 mm × 4.6 mm, 5 μm） column, methanol （A） and 0.25% acetic acid（B）as the mobile phase （A：0-90 min, 5%-＊98%） at 1.0 mL ·min ^- 1. The detection wavelength and column temperature were 280 nm and 25 ℃ . Results Fingerprint of water-extracting products of Qianlie＇an sup- pository was established, 12 batches of samples showed that the similarity was more than 0.9, and 26 characteristic peaks were selected as the fingerprint peaks. Conclusion of Qianlie＇an suppository.