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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 determine the characteristic map of methanol extract of Compound Danshen Tablets by HPLC and to lay the foundation for the quality control of compound Danshen Tablets. Methods HPLC method was used to establish the characteristic map of compound Salvia miltiorrhiza tablet. The relative retention time of each characteristic peak was calculated with tanshinone ⅡA as the reference peak. The relative retention time (RSD) of different characteristic peaks of different columns was investigated. Under the conditions of the relative retention time of each peak RSD; the establishment of 10 batches of compound Danshen HPLC profiles. Results The relative retention time (RSD) of each characteristic peak of different columns was less than 3%. The relative retention time (RSD) of each characteristic peak at different column temperatures was less than 2%. The relative retention time (RSD) less than 1%. Taking tanshinone IIA as the reference peak, the relative retention time was calculated and the average value was calculated as the characteristic peak, which were 0.44 (peak 1), 0.60 (peak 2) and 0.70 (peak 3), respectively. Conclusion The characteristic maps and characteristic peaks as the quality control method of compound Danshen Tablets are simple in operation and strong in applicability.