葛根芩连结肠定位片HPLC指纹图谱定性及定量分析

Qualitative and quantitative analysis of Gegen Qinlian Colonic Localization Tablet with HPLC fingerprint

目的:建立葛根芩连结肠定位片高效液相色谱法(HPLC)指纹图谱定性及定量分析方法。方法:采用HPLC,以Agilent Zorbax SB-C18(4.6mm×250mm,5μm)为色谱柱,以乙腈(b)-0.015mol/L磷酸二氢钾溶液为流动相梯度洗脱,检测波长:270nm;流速:1m L/min;柱温:30℃;进样量:10μL。检测时间:120min。采用指纹图谱相似度软件(2004a版)进行数据分析。结果:通过方法学考察建立了葛根芩连结肠定位片指纹图谱的定性定量检测方法,并对12批葛根芩连结肠定位片进行指纹图谱检测分析,共检测出35个共有峰,12批制剂相似度均大于0.9,制剂生产工艺稳定可行。结论:该方法具有可操作性,能有效控制葛根芩连结肠定位片的质量。

Objective： To establish a method to analyze Gegen Qinlian Colonic Localization Tablet qualitatively and quantitatively with HPLC fingerprint. Methods： Samples were analyzed with HPLC method, with Agilent ZORBAX SBC18（4.6mm×250mm, 5μm） as the chromatographic column and acetonitrile（B）-0.015mol/L potassium dihydrogen phosphate solution as the mobile phase to have the gradient elution. Wave length： 270 nm. Flow rate： 1m L/min. Column temperature： 30℃. Injection volume： 10μL. Detection duration： 120 min. Fingerprint similarity software（2004a version） was used for data analysis. Results： A qualitative and quantitative detection method for Gegen Qinlian Colonic Localization Tablet was established through methodological studies. Fingerprint analysis of 12 batches of Gegen Qinlian Colonic Localization Tablet were made to get a total of 35 common peaks with a similarity higher than 0.9 among all 12 batches, which confirmed the feasibility and stability of the manufacturing technique. Conclusion： This method is feasible and can effectively control the quality of Gegen Qinlian Colonic Localization Tablet.