Study on the qualitative and quantitative quality control methods of Hugan Buzure Granules
Objective To establish a thin layer chromatography(TLC)identification method for medicinal materials and a high-performance liquid chromatography(HPLC)content determination method for main components in Hugan Buzure Granules,to improve the quality standard,and to strengthen the controllability of the preparation quality.Methods TLC was used to identify esculetin in Cichorium intybus radix and semen,scopoletin in Foeniculum vulgare cortex and fructus,apigenin in Apium graveo-lens radix and semen,and hyperoside in Cuscuta chinensis semen.To establish HPLC method for the determination of esculetin in Hugan Buzure Granules.Chromatographic separation was performed on a SunFire C18 column(250 mm×4.6 mm,5 μm);The mobile phase was methanol(A)-1 mL∙L-1 phosphoric acid solution(B)with gradient elution:0-2 min,5%A;2-5 min,5%-27%A;5-30 min,27%A.The column temperature was 30℃,the flow rate was 1 mL·min-1,the injection vol-ume was 10 μL,and the detection wavelength was 349 nm.Results Esculetin,scopoletin,apigenin and hyperoside in Hugan Bu-zure Granules were identified by TLC.The spots were clear and well separated,and the negative control had no interference.Es-culetin had a good linear relationship in the range of 0.16-4.00 μg∙mL-1(r2= 0.9997,n=6).The RSD values of precision,re-peatability,stability and recovery were all less than 2.00%.The average content of esculetin in Hugan Buzure Granules was 2.66 μg∙g-1 with RSD 0.79%.Conclusion The established qualitative identification and content determination method is simple and reproducible,and can be used for the quality control of Hugan Buzure Granules.
Hugan Buzure Granulesqualitative identificationcontent determinationquality control
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NSTL
万方数据
维普
