壮骨关节丸HPLC指纹图谱研究

Study on HPLC fingerprints of Zhuanggu Guanjie Pills

目的建立壮骨关节丸HPLC指纹图谱,为其质量评价提供依据。方法采用HPLC法,Agilent Eclipse XDB-C18色谱柱(4.6 mm×250 mm,5μm),流动相为乙腈-0.1%乙酸水溶液,梯度洗脱,流速1 ml/min,柱温35℃,检测波长254 nm,进样量10μl,建立15批壮骨关节丸指纹图谱,并进行相似度分析,同时估测其中18个成分含量。结果指纹图谱研究中,以异补骨脂素为参照峰,标定40个共有峰,指认18个色谱峰,15批市售壮骨关节丸指纹图谱与对照指纹图谱的相似度>0.99。结论该方法便于操作、准确度高,可为壮骨关节丸的质量评价提供依据和参考。

Objective To establish the high performance liquid chromatography(HPLC)fingerprints of Zhuanggu Guanjie Pills,which provided the basis for its quality evaluation.Methods HPLC was used with Agilent Eclipse XDB-C18 column(4.6 mm×250 mm,5μm);mobile phase was acetonitrile-0.1%acetic acid water;gradient elution;flow rate was 1 ml/min;column temperature was at 35℃;detection wavelength was 254 nm;injection volume was 10μl.The HPLC fingerprints of 15 batches of Zhuanggu Guanjie Pills were established and similarity analysis was carried out,and the contents of 18 components were estimated.Results In the fingerprint study,isopsoralen was used as the reference peak,40 common peaks were marked and 18 peaks were identified and the similarity between the fingerprints of 15 batches of Zhuanggu Guanjie Pills and the control fingerprints was greater than 0.99.Conclusion This method is easy to operate and has high accuracy,which can provide basis and reference for the quality evaluation of Zhuanggu Guanjie Pills.