摘要
目的研究不同厂家和不同批次缩泉丸的HPLC指纹图谱,为完善该制剂的质量评价体系奠定基础。方法采用甲醇超声提取的方法制备供试品溶液,以乙腈-0.1%磷酸溶液梯度洗脱,流速:1 m L·min-1,柱温30℃,分段切换检测波长。结果建立了缩泉丸的HPLC指纹图谱共有模式,确立了14个共有峰,15批样品指纹图谱中各共有峰相对保留时间的相对标准偏差均<1.5%。结论该方法准确可靠、重复性好,建立的指纹图谱为缩泉丸质量评价提供依据。
Objective To study the difference in fingerprints of different batches of Suoquan pills from different manufacturers to support the foundation of quality control system of Suoquan pills. Methods The sample solution was prepared by ultrasonic extraction and HPLC was employed to separate ingredients by gradient elution with mixture of acetonitrile and 0.1% phosphate acid. The flow rate was 1 mL·min^- 1 and the column temperature was 30 ℃. Results The HPLC fingerprint of Suoquan pills was established, 14 common peaks were defined in different fingerprints. The relative standard deviation values of the relative retention time of 14 common peaks were less than 1.5%. Conclusion The method is reliable and accurate with good reproducibility, wihch could be used for the quality control of Suoquan pills.
出处
《中南药学》
CAS
2015年第11期1129-1131,共3页
Central South Pharmacy
