Qualitative and quantitative analysis of HPLC fingerprint of Wuji gastric floating sustained-release tablets  

戊己胃漂浮缓释片HPLC指纹图谱定性及定量分析(英文)

作　　者：陈中芬[1] 刘文[1] 陈大业[1] 施晓伟[1] 王群[1] 

机构地区：[1]贵阳中医学院,贵州贵阳550002

出　　处：《Journal of Chinese Pharmaceutical Sciences》2015年第5期310-317,共8页中国药学（英文版）

基　　金：The National Natural Science Foundation of China(Grant No.81460609)

摘　　要：A qualitative and quantitative test method of fingerprint of Wuji gastric floating sustained-release tablets was established. High performance liquid chromatography （HPLC） was adopted, using Agilent ZORBAX SB-C18 column （250 mm×4.6 mm, 5 μm） as the chromatographic column, and acetonitrile-0.05 mol/L potassium dihydrogen phosphate solution as the mobile phase in a gradient elution with the flow rate of 1.0 mL/min. Sample solution （10 μL） was injected and was tested at the wavelength of 225 nm for 75 min at the column temperature of 30 ℃, Fingerprint similarity software （2004A version） was used to conduct data analysis. A total of 11 batches of Wuji gastric floating sustained-release tablets were tested and analyzed with HPLC fingerprint. Seventeen common peaks were found and the similarity of the 11 batches of agents was greater than 0.9, indicating that the production process of the agent is stable and feasible. The method is operable and could effectively control the quality of Wuji gastric floating sustained-release tablets.我们建立了戊己胃漂浮缓释片指纹图谱的定性定量研究,以便更好地控制制剂质量。采用高效液相色谱法,Agilent ZORBAX SB-C18柱(250 mm×4.6 mm,5μm)为色谱柱,以乙腈–0.05 mol/L磷酸二氢钾溶液为流动相进行梯度洗脱,流速1.0 m L/min,检测波长225 nm,柱温30 ℃,进样量10μL,检测时间为75 min,采用指纹图谱相似度软件(2004A版)进行数据分析。通过方法学考察建立了戊己胃漂浮缓释片指纹图谱的定性定量检测方法,并对11批戊己胃漂浮缓释片进行指纹图谱检测分析,共检测出17个共有峰,11批制剂相似度均大于0.9,制剂生产工艺稳定可行。该方法具有可操作性,能有效控制戊己胃漂浮缓释片的质量。

关 键 词：FINGERPRINT HPLC Wuji gastric floating sustained-release tablets 

分 类 号：R286.0[医药卫生—中药学] O657.72[医药卫生—中医学]