金乌骨通胶囊HPLC指纹图谱研究

目的:建立金乌骨通胶囊的高效液相色谱指纹图谱分析方法,为金乌骨通胶囊药品质量评价积累数据。方法:采用反相高效液相色谱方法,以安捷伦Eclipse plus C18色谱柱(4.6mm×250mm,5μm);流动相为乙腈(A)-1%冰醋酸水溶液(B),梯度洗脱程序为:0~15min,9~10%A,流速1.0ml/min;15~65min,10~40%A,流速1.0ml/min;65~115min,40~70%A,流速1.5ml/min;115~125min,70%A,流速1.5ml/min;检测波长为0~60min为254nm,60~85min为380nm,85~125min为254nm;洗脱总时间为125min;柱温30℃;进样量20μl,进行指纹图谱研究。结果:建立金乌骨通胶囊高效液相指纹图谱,以淫羊藿苷色谱峰为参照峰,确定13个共有峰,共测定29批样品,样品指纹图谱的相似度均大于0.985。结论:本方法分离效果好,精密度、稳定性、重现性等指标均良好,可用于金乌骨通胶囊的产品质量控制及市场真伪品鉴别。

HPLC fingerprint of Jingwugutong Capsules

Objective To establish the HPLC fingerprint of Jingwugutong Capsules and accumulate data for evaluation of its quality. Methods The chromatographic fingerprints were determined with RP- HPLC on Agilent Eclipse plus C18 （4. 6mm × 250mm, 5μm） and with the gradient solvent system consisting of acetonitrile （A） and 1% AcOH solution （B）, 0 ~ 15min, 9 - 10% A, flow rate 1.0ml/min; 15 - 65min, 10 - 40% A, flow rate 1.0ml/min; 65 - 115min, 40 - 70% A, flow rate 1.5ml/min; 115 125min, 70% A, flow rate 1.5mL/min; the detection wavelength was set at： 0 - 60min 254nm, 60 - 85min 380nm, 85 - 125min 254nm, and the column temperature was maintained at 30℃. Results Based on the peaks of icariin as reference peak, measured value of twenty nine batches revealed that there were thirteen common peaks and high similarity between samples of fingerprints. Conclu- sion it is easy to handle for this method and has good separation effect, reproducibility, stability, precision, and can be applied to the quality control and the authenticity identification of Jingwugutong Capsules.