HPLC-DAD同时测定苦碟子注射液中7种黄酮类成分含量

Simultaneous Determination of Seven Flavonoids Constitutes in Kudiezi Injection by RP-HPLC-DAD

目的：建立HPLC-DAD同时测定苦碟子注射液中的7种黄酮类成分[木犀草素-7-O-龙胆二糖苷（LGT）、木犀草素-7-O-β-D-吡喃葡萄糖苷（LGCOP）、木犀草素-7-O-β-D-吡喃葡萄糖醛酸苷（LGCRP）、芹菜素-7-O-β-D-吡喃葡萄糖苷（AGCOP）、芹菜素-7-O-β-D-吡喃葡萄糖醛酸苷（AGCRP）、木犀草素（LI）、芹菜素（AGI）]含量的方法。方法：采用Waters Symmetry C18色谱柱（3.9 mm×150 mm，4.6 μm），流动相0.05%甲酸-乙腈和0.05%甲酸-水，梯度洗脱。流速1 mL·min^-1，柱温35 ℃，检测波长340 nm。结果：7种待测成分的分离度良好，线性关系良好，加样回收率为99.0%-101.5%，均符合含量测定要求。建立的方法能够同时测定LGT，LGCOP，LGCRP，AGCOP，AGCRP，LI，AGI的含量，并对8批苦碟子注射液进行含量测定，各黄酮含量在0.157 9-103.4 mg·L^-1。结论：该法简便可行，结果可靠，且能同时测定苦碟子注射液中7中黄酮类成分，可作为本制剂多成分内控质量的测定方法。

Objective： To develop an analysis method of simultaneously determining [luteolin-7-O-gentibioside （LGT）, luteolin-7-O-β-D-glucopyranoside （LGCOP）, luteolin-7-O-β-D-glucuronopyranoside （LGCRP）, apigenin-7-O-β-D-glucopyranoside （AGCOP）, apigenin-7-O-β-D-glucuronopyranoside （AGCRP）, luteolin （LI） and apigenin （AGI）] in Kudiezi injection by RP-HPLC-DAD. Method： 0.05% formic acid-acetonitrile and 0.05% formic acid-water as the mobile phase, chromatographic column was Waters Symmetry C18（3.9 mm×150 mm, 4.6 μm） in gradient elution mode with velocity：1 mL·min^-1, column temperature 35 ℃, detection wavelength of 340 nm. Result： There were perfect chromatogram with good separation. All the 7 calibration curves showed a good linear relationship. The recoveries were 99.0%-101.5%, according to the requirement. The developed method was successfully applied for the simultaneous determination of the 7 components （LGT,LGCOP,LGCRP,AGCOP,AGCRP,LI,AGI）. After the determination of 8 batch of Kudiezi injection, the content of 7 flavonoids was in 0.157 9-103.4 mg·L^-1. Conclusion： The method is convenient, specific, and can be used for the flavonoids constitutes quality control of Kudiezi injection.