HPLC法测定丹参类注射液中4种水溶性成分含量

目的采用HPLC法同时测定香丹注射液 (复方丹参注射液 )及丹参注射液中 4种水溶性成分丹酚酸B、迷迭香酸、丹参素和原儿茶醛含量。方法采用HypersilC18(2 5 0mm× 4 6mm ,5 μm)色谱柱 ;以甲醇 水 二甲基甲酰胺 冰醋酸为流动相梯度洗脱 ;流速为 1 0mL/min ;柱温为 35℃ ;检测波长 2 80nm。结果丹参素、原儿茶醛、迷迭香酸和丹酚酸B线性范围分别在 0 0 194～0 194 0 g·L-1、0 0 0 4 0 4～ 0 0 4 0 4 g·L-1、0 0 0 80 8～ 0 0 80 8g·L-1和 0 0 2 6 0～ 0 2 6 0 0 g·L-1内 ,线性关系良好 (r≥ 0 9998) ;加样回收率分别为 10 4 % ,98 3% ,10 1% ,10 3% ,RSD <2 0 %。结论本研究为丹参类注射液的质量综合评价和控制提供了简单、准确、可行的分析方法。

Simultaneous determination of 4 water-soluble components in danshen-containing injections by HPLC

Objective To develop a reversed-phase HPLC method for the simultaneous determintion of 4 water-soluble components,danshensu,protocatechuic aldehyde,rosmarinic acid and salvianolic acid B,in commercial compound danshen(traditional Chinese medicine,Salvia miltiorrhiza Bge.)injections and danshen injection.Method A gradient HPLC system was used in the quantitative analysis of the above 4 water-soluble components,including the ODS reversed-phase column of Hypersil C 18 (4.6 mm× 250 mm, 5 μm),the mixed solvents of methanol-water-dimethyl formamide-acetic acid at the flowrate of 1.0 mL·min -1.The eluate was monitored with UV absorption at 280 nm.Result The linear ranges of danshensu,protocatechuic aldehyde,rosmarinic acid and salvianolic acid B were 0.019 4～ 0.194 0 g·L -1, 0.004 04～ 0.040 4 g·L -1, 0.008 08～ 0.080 80 g·L -1 and 0.026 0～ 0.260 0 g·L -1( r≥ 0.999 8),respectively.The RSD were less than 2.0%,and the recoveries were from 98.3% to 104%.Conclusion The method is of good accuracy and a simple procedure.It may be practical to evaluate and control the quality of danshen-containing injections.