高效液相色谱法测定心可舒片中丹参素钠和原儿茶醛含量

Determination of Sodium Danshensu and Protocatechuic Aldehyde in Xinkeshu Tablets by HPLC

目的建立心可舒片中有效成分丹参素钠和原儿茶醛的含量测定方法。方法采用Waters Symmetry C18柱(150 mm×3.9 mm,3.5μm),以甲醇-0.5%醋酸溶液(10∶90)为流动相,检测波长为280 nm,流速为1.0 mL/min。结果丹参素钠质量浓度在50.06～250.30μg/mL范围内与峰面积呈良好线性关系,r=0.999 1,方法平均回收率为100.61%,RSD=1.23%(n=5);原儿茶醛质量浓度在5.28～47.52μg/mL范围内与峰面积呈良好线性关系,r=0.999 5,方法平均回收率为99.84%,RSD=1.69%(n=5)。结论 15批样品测定结果表明,该方法简便、准确,可用于心可舒片中丹参素钠和原儿茶醛的含量测定,为该药的质量评价提供了依据。

Objective To establish a method for simultaneous determination of the contents of sodium danshensu and protocatechuic aldehyde in Xinkeshu Tablets. Methods The HPLC method was carried out with the Waters Symmetry C1s column and methanol O. 5% acetic acid（10：90） as the mobile phase. The flow rate was 1.0 mL/min with the detective wavelength of 280 nm. Results The calibration curve of sodium danshensu as linear within the range of 50. 06- 250. 30 μg/mL（ r =0. 999 1）, the average recovery rate was 100.61%, RSD was 1.23% （n=5）.The calibration curve of protocatechuic aldehyde was linear within the range of 5.28-47.52 μg/mL （r =0. 999 5）, the average recovery rate was 99.84%, RSD was 1.69% （n = 5）. Conclusion The detection Results in 15 batches of samples show that this method is easy to operate, accurate, and can be used to determine the contents of sodium danshensu and proto catechuic aldehyde in Xinkeshu Tablets, and orovides the basis for the aualitv evaluation of Xinkeshu Tablets.