银杏酮酯-羟丙基-β-环糊精包合物的质量标准研究

Quality standard for inclusion complexes of GBE50 with HP-β-cyclodextrin

目的建立银杏酮酯-羟丙基-β-环糊精包合物的质量标准。方法采用高效液相色谱法测定制剂中的总黄酮苷含量,色谱柱：Diamonsil C18柱（250 mm×4.6 mm,5μm）,流动相：甲醇-0.4%磷酸（45∶55）,检测波长368nm,流速：1 mL·min^-1;采用红外光谱分析法鉴别包合物。结果槲皮素在2132μg·mL^-1与峰面积具有良好的线性关系,r=0.999 5;山奈素在0.960μg.mL-1与峰面积具有良好的线性关系,r=0.999 8;异鼠李素在0.19μg·m^L-1与峰面积具有良好线性,r=0.999 8。槲皮素、山奈素、异鼠李素的平均回收率分别为101.6%、100.4%、99.3%,RSD分别为1.3%,1.4%,0.63%。红外光谱法能有效鉴别包合物。结论本法可作为该制剂的质量控制参考标准。

Objective To develop a quality control method for inclusion complexes of GBE50 with HP-β-cyclodextrin.Methods The content of quercetin,kaempferol and isorhamnetin was determined by HPLC.The separation was performed on a Diamonsil C18 column（250 mm ×4.6 mm）.The mobile phase consisted of methanol and 0.4% phosphate（45∶55）,the detective wavelength was 368 nm,the flow rate was 1 mL·min-1,and the inclusion complexes were identified by infrared spectrum（IR）.Results The linear ranges of quercetin,kaempferol and isorhamnetin were 2-132 μg·mL-1,0.9-60 μg·mL-1,and 0.1-9 μg·mL-1 respectively.The average recovery was 101.6%,100.4%,and 99.3% respectively;RSD=1.3%,1.4%,and 0.63%.The inclusion complexes were identified by IR.Conclusion The method is stable and reliable with good reproducibility,which can be used for the quality control of GBE50 with HP-β-cyclodextrin.