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目的:建立丹参益坤口服液中丹参酮ⅡA、丹参酮Ⅰ及隐丹参酮含量的HPLC测定方法。方法:采用Wonda Sil C18-WR(200 mm×4.6 mm,5μm)色谱柱;以甲醇-0.5%冰醋酸溶液(65∶35)为流动相;流速为1.0 m L/min;柱温为30℃;检测波长为274 nm。结果:丹参酮ⅡA在0.28~5.60μg范围内与峰面积呈良好线性关系,r1=0.9999,平均加样回收率为99.12%,RSD为0.52%;丹参酮Ⅰ在0.29~5.80μg范围内与峰面积呈良好线性关系,r2=0.9996,平均加样回收率为99.36%,RSD为0.63%;隐丹参酮在0.218~4.36μg范围内与峰面积呈良好线性关系,r3=0.9992,平均加样回收率为99.02%,RSD为0.68%。结论:所建立的测定方法简单,易于操作,重现性好,可作为丹参益坤口服液质量控制标准。
Objective: To establish a HPLC method for the determination of tanshinone Ⅱ A, tanshinone Ⅰ and cryptotanshinone in Salvia miltiorrhiza Yikun oral solution. Methods: A Wonda Sil C18-WR (200 mm × 4.6 mm, 5 μm) column was used. The mobile phase was methanol-0.5% glacial acetic acid (65:35) at a flow rate of 1.0 mL / ; Detection wavelength of 274 nm. Results: Tanshinone Ⅱ A had a good linear relationship with the peak area in the range of 0.28 ~ 5.60 μg with r1 = 0.9999, the average recovery was 99.12% and the RSD was 0.52%. The peak area of tanshinone Ⅰ in the range of 0.29 ~ 5.80 μg was R2 = 0.9996, the average recovery was 99.36% and the RSD was 0.63%. There was a good linear relationship between the concentration of cryptotanshinone and the peak area in the range of 0.218 ~ 4.36μg, r3 = 0.9992, the average recovery was 99.02 %, RSD 0.68%. Conclusion: The established determination method is simple, easy to operate, reproducible, and can be used as quality control standard Salvia Yikun oral solution.