UPLC法测定心舒宝片中11种酚酸类成分的含量

Determination of 11 phenolic acid components in Xinshubao tablets by UPLC method

目的:建立超高效液相色谱法(UPLC)测定心舒宝片中11种酚酸类成分的含量,为心舒宝片的质量评价奠定基础。方法:采用Welch Ultimate XB-C18(2.1 mm×150 mm,1.8μm)色谱柱;柱温为25℃;梯度洗脱;流速0.2 mL·min^(-1);检测波长为320 nm;进样量为3μL。利用UPLC法对心舒宝片中包括没食子酸、丹参素、原儿茶酸、新绿原酸、原儿茶醛、绿原酸、隐绿原酸、迷迭香酸、紫草酸、丹酚酸B、丹酚酸A等11种化学成分进行定量分析。结果:在考察的浓度范围内,各化学成分均具有良好的线性关系(r>0.9994),回收率均在98.37%~101.15%,RSD在1.20%~2.81%,且精密度、稳定性和重复性均符合分析要求。结论:本实验采用UPLC法高效、快速、全面地对心舒宝片的11种质量标志物进行分析与含量测定,为心舒宝片药效物质基础研究及生物效应质量评价奠定基础。

Objective:To establish an ultra high performance liquid chromatography(UPLC)method for the determination of 11 phenolic acid components in Xinshubao tablets,laying a foundation for the quality evaluation of Xinshubao tablets.Method:Using Welch Ultimate XB-C18(2.1 mm)×150 mm,(1.8μm)Chromatographic column;The column temperature is 25℃;Gradient elution;Flow rate 0.2 mL·min^(-1);The detection wavelength is 320 nm;Injection volume of 3μL.Using UPLC method to quantitatively analyze 11 chemical components in Xinshubao tablets,including gallic acid,danshensu,protocatechuic acid,neochlorogenic acid,protocatechuic aldehyde,chlorogenic acid,cryptochlorogenic acid,rosmarinic acid,purpuric acid,salvianolic acid B,and salvianolic acid A.Result:Within the concentration range under investigation,all chemical components showed good linear relationships(r>0.9994),with recovery rates ranging from 98.37%to 101.15%and RSD ranging from 1.20%to 2.81%.The precision,stability,and repeatability all met the analytical requirements.Conclusion:The UPLC method was used in this experiment to efficiently,quickly,and comprehensively analyze and determine the content of 11 quality markers in Xinshubao tablets,laying the foundation for the study of the pharmacological substance basis and the evaluation of the biological effect quality of Xinshubao tablets.