高效液相色谱法测定丹参川芎嗪注射液中丹参酮ⅡA与川芎嗪的含量

Determination of tanshinone ⅡA and ligustrazine in Salvia Ligustrazine Injection by HPLC

目的:建立丹参川芎嗪注射液中丹参酮ⅡA与川芎嗪的含量测定方法。方法:采用高效液相色谱(HPLC)法进行测定,色谱柱为AlltimaC18柱(4.6mm×250mm,5μm),测定丹参酮ⅡA以甲醇-水(75∶25)为流动相,测定川芎嗪以甲醇-水(60∶40)为流动相;流速均为1.0ml/min;检测波长分别为271nm与296nm。结果:丹参酮ⅡA与川芎嗪在0.002～0.020mg/ml浓度内与峰面积线性关系良好,r分别为0.9921,0.9930,平均回收率分别为99.99%,99.75%,RSD分别为0.19%,0.48%(n=5)。结论:该方法灵敏度高、准确,测定结果重现性好,适用于丹参川芎嗪注射液的质量控制。

Objective： To establish the content determination methods of tanshinone Ⅱ A and ligustrazine in Salvia Ligustrazine Injection.Methods： HPLC was used, column was Alltima C18 column （4.6 mm×250 mm, 5 um）, the mobile phase was methanol-water （75：25） in the determination of tanshinone Ⅱ A, and methanol-water （60：40） in the determination of ligustrazine, the flow rate was 1.0 ml/min, detection wavelength was set at 271 nm and 296 nm. Results： There was a good linear relationship at the range of 0.002-0.020 mg/ml of tanshineone Ⅱ A（r=0.992 1） and ligustrazine（r=0.993 0）,the average recovery was 99.99% and 99.75%, RSD was 0.19% and 0.48%（n=5）, respectively.Conclusion：The method is sensitive,accurate and reprodnible, it can be used for the quality control of Salvia Ligustrazine Injection.