脑心清片HPLC-DAD指纹图谱的研究

Study on HPLC-DAD Fingerprint of Naoxinqing Tablets

目的建立脑心清片HPLC-DAD指纹图谱的分析方法,以控制脑心清片的质量。方法采用HPLC-DAD法,色谱柱为Agilent TC-C1(84.6 mm×250 mm,5μm);流动相:乙腈-0.2%磷酸水溶液梯度洗脱,柱温25℃,体积流量1.0 mL/min,检测波长256 nm,记录时间60 min。使用计算机辅助相似度评价软件进行数据处理,对不同批次的脑心清片指纹图谱的相似度进行比较分析。结果 18批脑心清片的指纹图谱存在一定的差异性,从共有模式色谱图中共找到16个共有峰。结论所建立的方法稳定、重现性好,能显示脑心清片的内在质量,为脑心清片的质量控制提供了科学依据。

Objective To establish a HPLC-DAD fingerprint analysis method for Naoxinqing tablets. Methods HPLC-DAD method was performed on a Agilent TC-Cls （4.6 mm ~ 250 ram, 5 txm）with acetonitrile-0.2% phospho- ric acid as mobile phase by gradient elution. The flow rate was 1.0 mL/min, column temperature was 25℃, the de- tection wavelength was at 256 nm, and fingerprinting time lasted 60 rain. The computer-assisted software for evaluat- ing the fingerprint similarity was adopted to process the experimental data and to compare the similarity of HPLC finger- prints of Naoxinqing tablets of different batches. Results Certain differences existed in HPLC-DAD fingerprints of 18 batches of Naoxinqing tablets, and 16 common peaks were found in the HPLC figerprints. Conclusion The established method is stable and reproducible, which can be used for the identification of the interior quality, and the results wil] provide the reference for the quality control of Naoxinqing tablets.