HPLC法测定药典方丹参片中丹参酮ⅡA及丹酚酸B的含量

Quantitative determination of tanshinone ⅡA and salvianolic acid B in pharmacopoeial prescription Danshen Tablets by HPLC

目的:完善药典方丹参片的质量标准,测定制剂中丹参酮ⅡA及丹酚酸B的含量,考察制备工艺中有效成分的转移率。方法:采用HPLC法进行含量测定。丹参酮ⅡA,以甲醇-水(80∶20)为流动相,检测波长为270nm;丹酚酸B以甲醇-乙腈-甲酸-水(30∶10∶1∶59),检测波长为286nm。结果:3批丹参片平均含丹参酮ⅡA2.83mg/g,转移率为42.3%;丹酚酸B含量为51.8mg/g,转移率为50.9%。结论:建立了丹参片中丹参酮ⅡA的含量测定方法,可以更好地控制丹参片的质量。

Objective： To determine tanshinoneⅡA and salvianolic acid B in Danshen Tablets quantitatively. Methods： HPLC with Hypersil ODS column was used in the content determination. For tanshinoneⅡA , the mobile phase was composed of methanol-water （80∶20） and the detective wavelength was at 270 nm. For salvianolic acid B, the mobile phase was composed of methanol-acetonitrile-formic acid-water （30∶10∶1∶59） and the detective wavelength was at 286 nm. Results： The average contents of tanshinoneⅡA and salvianolic acid B in three batch of tablets were 2.83 mg/g and 51.8 mg/g respectively. The extraction rate of the preparation processes were 42.3% and 50.9% respectively. Conclusion： The method is available with a good reproducibility and can control the quality of Danshen Tablets effectively.