益心酮片HPLC指纹图谱的构建

CONSTRUCTION OF HPLC FINGERPRINT OF YIXINTONG TABLETS

目的:构建益心酮片的HPLC指纹图谱。方法:采用HPLC法建立13批益心酮片的指纹图谱。色谱条件:ZORBAX SB-C18色谱柱(5μm,4.6mm×250mm),流动相为A:0.1%甲酸-水混合溶液、B:乙腈、C:四氢呋喃,梯度洗脱,流速为1.0ml/min,检测波长350nm,柱温30℃,进样量10μl。使用中药指纹图谱相似度评价软件(版本2004 A)进行相似度分析。结果:根据13批益心酮片的指纹图谱检测结果,共标定出10个共有峰,13批益心酮片的相似度均大于0.99。结论:该方法操作简单、可靠,重复性强,结果比较稳定,适用于益心酮片的质量评价。

Objective：To construct the HPLC fingerprint of Yixintong tablets. Methods： The HPLC was used to construct the fingerprint of 13 batches Yixintong tablets with the condition that the column was ZORBAX SB-C18 column（5μm, 4.6 mm×250 mm）; the mobile phase was eluted with gradient by 0.1% formic acid-water, acetonitrile and tetrahydrofuran; the flow rate was 1.0 ml/min; the detection wavelength was 350 nm; the column temperature was 30℃; the sample volume was 10μl. The similarity evaluation software（2004 A version） was used for similarity analysis. Results： The HPLC fingerprints of 13 batches Yixintong tablets calibrated 10 common peaks, and the similarity were all higher than 0.99. Conclusions： The method is simple, stable and feasible, and can be used to evaluate the quality of Yixintong tablets.