【摘要】 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。更多还原

【Abstract】 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 suppository 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 The method is reliable and helpful in the effective control of Qianlie’an suppository.更多还原