HPLC法同时测定骨刺宁胶囊中三七皂苷R_1、人参皂苷Rg_1、人参皂苷Rb_1

Determination of three active components in Guciling Granules by HPLC

目的用高效液相色谱梯度洗脱法同时测定骨刺宁胶囊(三七、土鳖虫)三七皂苷R1、人参皂苷Rg1和人参皂苷Rb1,为制定该制剂质量标准中定量测定方法及限度提供依据。方法色谱柱为kromasilTM C18分析柱(4.6 mm×150mm,5μm);以乙腈-水梯度洗脱(0～12 min:乙腈质量分数为19%;12～60 min乙腈质量分数由19%递升至36%);体积流量1 mL/min,检测波长203 nm,柱温25℃,进样量10μL。结果三七皂苷R1、人参皂苷Rg1和人参皂苷Rb1的线性范围分别为0.922～5.534μg、1.337～8.021μg和1.032～6.182μg。平均加样回收率(n=6)分别为99.47%、99.02%和99.12%。结论 HPLC梯度洗脱法能将多种皂苷很好地分离检测,提高了时效,减少了误差。该方法简便可行、准确可靠,重现性好,结果稳定。可用于骨刺宁胶囊中三七多种有效成分的定量测定。

AIM To establish a method for determing notoginsenoside R1,ginsenoside Rg1 and ginsenoside Rb1 in Guciling Granules（Notoginseng Radix et Rhizoma,Eupolyphaga or Steleophaga）.METHODS The HPLC method was carried out on kromasil TMC18 column（4.6 mm×150 mm,5 μm）.The mobile phase was acetonitrile-water（0-12 min：19∶ 81;12-60 min：36∶ 64）.The flow rate was 1.0 mL/min.The detection wavelength was at 203 nm.The column temperature was set at 25 ℃.RESULTS The linearity was in the ranges of 0.922-5.534 μg、1.337-8.021 μg and 1.032-6.182 μg,respectively.Their average recoveries were 99.47%、99.02% and 99.12%,respectively.CONCLUSION The method is simple,accurate and reproducible to quantify the three active components in Guciling Granules.