高效液相色谱法测定二丁颗粒中活性成分

Determination of Active Components in Erding Granules by High Performance Liquid Chromatography

目的采用高效液相色谱法(High performance liquid chromatography,HPLC)测定中成药二丁颗粒中2种活性成分。方法采用安捷伦C18色谱柱(250 mm×4.6 mm,5.0μm),以0.05%三氟乙酸溶液和乙腈作为本研究的流动相,不断调整二者比例,随时间不同进行洗脱(0~15 min,5%~15%;15~25 min,15%;25~45min,15%~25%);检测波长:315 nm(0~35 min),350 nm(35~40 min);体积流量1.0 m L/min;柱温30℃。结果各分离峰之间的分离度均大于1.5,色谱峰形态正常,并且主要活性成分咖啡酸和秦皮乙素的理论塔板数高于4000;所测成分线性范围分别为0.249~2.570μg/m L,和2.390~25.000μg/m L(r≥0.9998);平均回收率在95%~105%。结论该方法简单易行、灵敏度较高、测量较准确,可作为二丁颗粒的质量控制方法。

Objective To establish a high performance liquid chromatography method for the determination of two active components in Erding granules.Methods AgilentC18 column(250 mm 4.6 mm,5.0 m)was used.The chromatographic conditions were AgilentC18 column(250 mm×4.6 mm,5.0μm),mobile phase A:0.05%CF3COOH solution,mobile phase,B:CH3CN solution,gradient elution(0~15 min,5~15%;15~25min,15%;25~45 min,15%~25%).The detection wavelength was 315 nm(0~35 min),350nm(35~40 min),the volume flow rate was 1.0 ml/min,the column temperature was 30℃,Results the linear range of the three active components was 0.249~2.570μg/mL,and 2.390~25.000μg/mL R=0.9998,respectively.The average recoveries were between 95%~105%.The separation degree of each peak was greater than 1.5,and the chromatographic peaks were normal in shape.The theoretical plate number of the main active components,caffeic acid and aesculetin was higher than 4000.Conlusion The method is scientific and reliable and can be used for the quality control of Erding granules.