摘要
目的:建立胃可宁片高效液相色谱指纹图谱,为其质量控制提供比较全面的方法。方法:采用异硫氰酸苯酯(PITC)为衍生试剂,与胃可宁片中氨基酸等化合物柱前衍生,高效液相色谱法测定,Venusil AA(4.6 mm×250 mm,5 mm)作为色谱柱,柱温40℃,流速为1.0 ml/min,检测波长254 nm,用流动相A[乙腈-水(80∶20)]和B[0.1 mol/L醋酸钠水溶液(pH 6.5)]的混合液进行梯度洗脱。结果:建立了胃可宁片指纹图谱方法,确定了12个共有峰,10批样品的相似度均大于0.95,同时分析了共有峰的来源。结论:该方法准确可控,可用于胃可宁片的质量控制和评价。
Objective:To establish HPLC fingerprint of Weikening tablets to provide a comprehensive evaluation for their quality control.Methods:HPLC determination was performed on a Venusil AA column(4.6 mm×250 mm,5 mm)at column temperature 40℃,flow rate 1.0 ml/min and detection wavelength 254 nm by gradient elution with mobile phase A(acetonitrile-water(80:20))and B(0.1 mol/L sodium acetate buffer solution(pH 6.5))after pre-column derivatization of amino acids in Weikening tablets with phenyl isothiocyanate(PITC)was completed.Results:The HPLC fingerprint of Weikening tablets was established and twelve peaks of amino acids were selected as the common peaks of fingerprint for Weikening tablets.The similarity of ten batches of Weikening tablets was all more than 0.95.At the same time,the source of these common peaks was elucidated.Conclusion:This method is accurate and controllable,and can be used for the quality control and evaluation of Weikening tablets.
作者
沈丹萍
张正光
詹常森
SHEN Danping;ZHANG Zhengguang;ZHAN Changsen(Shanghai Hutchison Pharmaceuticals Co.,Ltd.,Shanghai 201401,China;Shanghai Engineering Research Center for Innovation of Solid Preparation of TCM,Shanghai 201401,China)
出处
《上海医药》
CAS
2019年第15期108-112,共5页
Shanghai Medical & Pharmaceutical Journal
关键词
胃可宁片
氨基酸
柱前衍生化
指纹图谱
Weikening tablets
amino acids
pre-column derivatization
fingerprint
