HPLC同时测定裸花紫珠系列制剂中6种成分的含量

Simultaneous Determination of 6 Constituents in Luohua Zizhu Series Preparations by HPLC

关键词:  裸花紫珠系列制剂  高效液相色谱法  含量测定  质量控制

Key words:  Luohua Zizhu series preparations  HPLC  content determination  quality control

摘要:

目的 建立HPLC同时测定裸花紫珠系列制剂中咖啡酸、连翘酯苷B、木犀草苷、毛蕊花糖苷、异毛蕊花糖苷和木犀草素的含量。方法 采用Agilent ZORBAX SB-C₁₈色谱柱（250 mm×4.6 mm，5 μm）；流动相为乙腈-0.15%磷酸，梯度洗脱，流速为1.0 mL·min^–1；柱温为30℃；进样量为10 μL；检测波长分别为330 nm （检测咖啡酸、连翘酯苷B、毛蕊花糖苷、异毛蕊花糖苷）和350 nm （木犀草苷、木犀草素）。结果 咖啡酸、连翘酯苷B、木犀草苷、毛蕊花糖苷、异毛蕊花糖苷和木犀草素线性范围分别为2.102~21.02，13.10~131.0，3.895~38.95，9.472~94.72，10.73~107.3，1.144~11.44 μg·mL^–1，相关系数r≥0.999 8；平均加样回收率分别为101.02%，97.36%，101.72%，100.14%，96.35%，98.26%，RSD分别为1.28%，0.68%，1.00%，1.47%，1.22%，2.34%。结论 该方法简单准确，重复性好，可用于裸花紫珠系列制剂的质量评价，为裸花系列制剂通用标准的建立提供参考。

Abstract:

OBJECTIVE To establish an HPLC method for the simultaneous content determination of caffeic acid, forsythoside B, luteolosie, acteoside, isoacteoside and luoteolin in Luohua Zizhu series preparations. METHODS The analysis was performed on Agilent ZORBAX SB-C₁₈ column(250 mm×4.6 mm, 5 μm) with gradient elution of acetonitrile-0.15% phosphoric acid solution at a flow rate of 1.0 mL·min^-1. The column temperature was 30℃, the injection volume was 10 μL and the detection wavelength was set at 330 nm for caffeic acid, forsythoside B, acteoside, isoacteoside, and 350 nm for luteolosie and luoteolin. RESULTS The linear ranges were 2.102-21.02 μg·mL^-1 for caffeic acid, 13.10-131.0 μg·mL^-1 for forsythoside B, 3.895-38.95 μg·mL^-1 for luteolosie, 9.472-94.72 μg·mL^-1 for acteoside, 10.73-107.3 μg·mL^-1 for isoacteoside, 1.144-11.44 μg·mL^-1 for luoteolin, respectively. The correlation coefficients(r) were ≥ 0.999 8. The average recoveries were 101.02%, 97.36%, 101.72%, 100.14%, 96.35% and 98.26%, RSDs were 1.28%, 0.68%, 1.00%, 1.47%, 1.22%, 2.34%, respectively. CONCLUSION This simple, accurate and reproducible method can be used for the quality evaluation of Luohua Zizhu series preparations, and provide reference for the general standard development of Luohua Zizhu series preparations.