复方丹参片的HPLC特征图谱研究

A Study on HPLC of The Characteristic Spectrum of Danshen Tablets

目的采用HPLC测定复方丹参片的甲醇提取液的特征图谱,为复方丹参片在定性定量质量控制方面奠定基础。方法采用HPLC法建立复方丹参片特征图谱,并进行方法学考察,以丹参酮ⅡA为参照峰,计算各特征峰的相对保留时间,考察不同色谱柱各特征峰的相对保留时间的RSD、不同柱温条件下各特征峰的相对保留时间的RSD;建立10批复方丹参片的HPLC特征图谱。结果不同色谱柱各特征峰的相对保留时间RSD均小于3%;不同柱温各特征峰的相对保留时间的RSD均小于2%;10批复方丹参片的HPLC特征峰的相对保留时间的RSD均小于1%。以丹参酮ⅡA为参照峰,计算得到的相对保留时间,求取平均值作为特征峰,分别是0.44(峰1)、0.60(峰2)、0.70(峰3)。结论特征图谱及特征峰作为复方丹参片质量控制方法,操作简单,适用性强。

Objective To evaluate the characteristic spectrum for the quality control of Danshen tablets.Method The Characteristic spectrum of Danshen tablets was established by HPLC method.In methodological study,Tanshinonel IIA was selected as the reference peak to calculate the RSD of the relative retention time and relative peak area of each common peak.Precision,stability and reproducibility were investigated as well.10 batches of Danshen tablets were included in this study.Result The RSD of the relative retention time and relative peak area of common peaks about precision,accuracy, repeatability were less than 3%.The RSD of the relative retention time of characteristic peaks under different column temperature were less than 2%.Taken Tanshinonel IIhas reference,the RSD of relative retention time in 10 batches Danshen Tablets was less than l%.The average relative retention time of three characteristic peaks was 0.44 （Peak 1）,0.60 （Peak 2）,0.70 （Peak 3）,respectively. Conc I us i on Characteristic spectrum was an accurate and reliable method for the quality evaluation of Danshen tablets.