UPLC法同时测定乙肝扶正胶囊中阿魏酸和藁本内酯的含量  

Simultaneous determination of ferulic acid and ligustilide in Yigan Fuzheng capsules by UPLC

作　　者：傅超 钟建青 殷世宁 宿曼筠 袁航 李晨 惠军 FU Chao;ZHONG Jian-qing;YIN Shi-ning;SU Man-yun;YUAN Hang;LI Chen;HUI Jun(Department of Chinese Medcine, Qingdao Institute for Drug and Food Control, Qingdao 266071, Shandong Province, China;Department of Pharmacy, Qingdao Fuwai Cardiovascular Disease Hospital,Qingdao 266000,Shandong Province,China;Department of Pharmacy, Qingdao Jiaozhou People’s Hospital,Qingdao 266000,Shandong Province,China)

机构地区：[1]青岛市食品药品检验研究院中药部,山东青岛266071 [2]青岛阜外心血管病医院药剂科,山东青岛266000 [3]青岛市胶州人民医院药剂科,山东青岛266000

出　　处：《中国临床药理学杂志》2019年第15期1663-1665,共3页The Chinese Journal of Clinical Pharmacology

摘　　要：目的建立超高效液相色谱法同时测定乙肝扶正胶囊中阿魏酸和藁本内酯含量的方法。方法用超高效液相色谱法,色谱柱:Waters Acquity UPLC BEH C18(100. 0 mm×2. 1 mm,1. 7μm);流动相:甲醇-0. 1%磷酸(70∶30);流速:0. 1m L·min^-1;检测波长:316 nm;柱温:30℃。考察该方法的专属性、标准曲线与定量下限、精密度与回收率、稳定性和重现性。结果阿魏酸在1. 98~39. 64μg(r=0. 998 4),藁本内酯在2. 42~48. 40μg(r=0. 999 7)线性关系良好,阿魏酸低、中、高3个质量浓度平均加样回收率分别为99. 60%,99. 32%,99. 56%;藁本内酯低、中、高3个质量浓度平均加样回收率分别为98. 45%,98. 37%,98. 58%(n=3)。结论本方法稳定、准确,重复性好,可作为乙肝扶正胶囊质量控制方法。Objective To develop a UPLC method for simultaneous de- termination of ferulic acid and ligustilide in Yigan Fuzheng capsules. Methods The analysis was performed by Waters Acquity UPLC BEH C 18 ( 100. 0 mm ×2. 1 mm,1. 7 μm) column. The mobile phase consis- ted of methanol -0. 1% phosphoric acid ( 70∶ 30). The flow rate was 0. 1 mL·min^-1 . The detection wavelength was 316 nm and column tempera- ture was 30 ℃. The specificity,standard curve and quantitative lower limit,precision and recovery,stability and repeatability of the method were investigated. Results Ferulic acid and ligustilide were separated perfectively. The standard curves were liner within the concentration ran- ges of 1. 98 -39. 64 μg for ferulic acid( r =0. 998 4) and 2. 42 -48. 40 μg for ligustilide( r =0. 999 7). The average sampling recoveries of the low,medium, and high mass concentrations of ferulic acid were 99. 60%,99. 32% and 99. 56%;those of ligustilide were 98. 45%, 98. 37% and 98. 58%( n = 3). Conclusion The method is stable, accurate and reproducible,which can be used for the quality control of Yigan Fuzheng capsules.

关 键 词：超高效液相色谱法 阿魏酸 藁本内酯 乙肝扶正胶囊 

分 类 号：R28[医药卫生—中药学]