双波长HPLC法同时测定清肝片中三种成分

Simultaneous Determination of Three Components in QingGan Tablets by Dual Wavelength HPLC

目的建立清肝片中(R,S)-告依春、甘草酸和绿原酸的含量测定方法,提高对三种成分的定性、定量的准确性,实现对清肝片的整体质量控制。方法采用双波长高效液相色谱法同时测定三种成分,流动相为乙腈-0.05%磷酸溶液,梯度洗脱,流速:0.9 mL·min^-1,检测波长为:245 nm[(R,S)-告依春、甘草酸],327 nm(绿原酸),柱温为30℃,进样量为10μL。结果检测限为[(R,S)-告依春:0.26 ng,甘草酸:2.0 ng,绿原酸:4.4 ng],精密度、稳定性、重复性试验的RSD均<2.0%,加样回收率%分别为[(R,S)-告依春:99.6%,甘草酸:95.7%,绿原酸:93.4%]。结论该方法操作简便,结果准确、灵敏度高、重复性好,可用于清肝片中(R,S)-告依春、甘草酸、绿原酸的含量的同时测定。

OBJECTIVE To establish a method for determining the content of(R,S)-Gaoyichun,glycyrrhizic acid,and chlorogenic acid in QingGan Tablets,to improve the qualitative and quantitative accuracy of the three components,and to achieve the whole QC.METHODS Simultaneous determination of three components by dual-wavelength high performance liquid chromatography,mobile phase was acetonitrile-0.05%phosphoric acid solution,gradient elution,flow rate:0.9 mL·min-1,detection wavelength:245 nm〔(R,S)-Gaoyichun,glycyrrhizic acid〕,327 nm(chlorogenic acid),column temperature 30℃,injection volume 10μL.RESULTS The detection limit were as follow:(R,S)-Gaoyichun:0.26 ng,glycyrrhizic acid:2.0 ng,chlorogenic acid:4.4 ng,the RSD of precision,stability,and repeatability test were all less than 2.0%,plus The sample recovery percentages were as follows:(R,S)-Gaoyichun:99.6%,glycyrrhizic acid:95.7%,chlorogenic acid:93.4%.CONCLUSION The method is simple,accurate,highly sensitive and reproducible.It can be used for the simultaneous determination of(R,S)-Gaoyichun,glycyrrhizic acid and chlorogenic acid in QingGan Tablets.