HPLC-DAD法对扶正平消胶囊中龙胆苦苷的含量研究
Determination of gentiopicrin in Fuzhengpingxiao capsule by HPLC-DAD
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摘要: 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, 5 μm),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4.88~97.60 μg/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0.244 μg/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。Abstract: Objective To develop a high performance liquid chromatograph method for determination of gentiopicrin in Fuzhengpingxiao 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 0.244 μg/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.
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Key words:
- HPLC /
- gentiopicrin /
- Fuzhengpingxiao capsule /
- quality standard
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