HPLC-DAD法对扶正平消胶囊中龙胆苦苷的含量研究

目的建立用高效液相色谱法(HPLC)测定扶正平消胶囊中龙胆苦苷的含量测定方法,并将测定方法作为此制剂的质量控制指标。方法采用Agilent 1100系列高效液相色谱仪,色谱柱Agilent Zorbax XDB-C8(4.6 mm×150 mm,5μm),流动相为甲醇-水(19∶81),检测波长275 nm,流速1 ml/min,柱温为25℃。结果龙胆苦苷含量在4.88～97.60μg/ml的范围内线性关系良好,标准曲线方程为Y=23.82X-7.170(r=0.999 9);其中日内精密度RSD<2%,日间精密度RSD<3%,最低定量限为0.244μg/ml,回收率为99.39%。结论本法专属性强,灵敏度高,选择性好,可用于测定扶正平消胶囊中龙胆苦苷的含量。

Determination of gentiopicrin in Fuzhengpingxiao capsule by HPLC-DAD

Objective To develop a high performance liquid chromatograph method for determination of gentiopicrin inFuzhengpingxiao capsule which could be used as a quality control indicator. Methods The separation was performed by 1100 series high performance liquid chromatograph, on an Agilent Zorbax XDB-C8 column （4.6 mm× 150 mm, 5 μm） ,using the methanol-water （ 19 ： 81 ） as the mobile phase, and the analysis was detected by UV spectrometry at 275 nm with flowing rate at 1 ml/min, the column tempreture was 25 ℃. Results He correlation coefficient of the calibration curve was better than 1 in the range 4.88 -97.60 μg/ml and the calibration curve was Y = 23.82X -7. 170. The relative standard deviation （RSD） of day to day precision was less than 3% and within-day precision was less than 2%. The lowest limit of quantification was 0. 244μg/ml. The sample recovery of Fuzhengpingxiao capsule was 99.39%. Conclusions This quantitative assay with better specificity, higher sensibility and could be used to determinate gentiopicrin in Fuzhengpingxiao capsule.