Research on Quality Standard of Shanzhajing Jiangzhi Capsule
Yu Hua
Abstract
Yu Hua
Abstract
Objective To establish the method for the quality control of Shanzhajing Jiangzhi capsule by HPLC so as to determine the content of ursolic acid and TLC with Fructus Crataegi as reference substance respectively.Methods Methylbenzene-ethyl acetate-formic acid(20∶4∶0.5) was used as developer for TLC and Alltima C18 column(5 μm,4.6 mm×250 mm) was adopted with acetonitrile-methanol-H2O-ammonium acetate(70∶16∶14∶0.5) as mobile phase,the detection wavelength was 220nm,the column temperature was 25℃,and the mobile phase speed was 1.0 ml per min for HPLC.Results The picture of TLC was clear and negative control had no interference.The calibration curve was linear at a range of 1.7968 to 17.9780 μg for ursolic acid content and the linear equation was Y=44 820X+5 725.5(r=0.999 9).The average recovery ratio was 101.17% and the relative standard deviation was 1.02%.Conclusion TLC and HPLC methods are convenient,fast,accurate,repeatable and special,and can be used to control Shanzhajing Jiangzhi capsule.
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Objective To establish the method for the quality control of Shanzhajing Jiangzhi capsule by HPLC so as to determine the content of ursolic acid and TLC with Fructus Crataegi as reference substance respectively.Methods Methylbenzene-ethyl acetate-formic acid(20∶4∶0.5) was used as developer for TLC and Alltima C18 column(5 μm,4.6 mm×250 mm) was adopted with acetonitrile-methanol-H2O-ammonium acetate(70∶16∶14∶0.5) as mobile phase,the detection wavelength was 220nm,the column temperature was 25℃,and the mobile phase speed was 1.0 ml per min for HPLC.Results The picture of TLC was clear and negative control had no interference.The calibration curve was linear at a range of 1.7968 to 17.9780 μg for ursolic acid content and the linear equation was Y=44 820X+5 725.5(r=0.999 9).The average recovery ratio was 101.17% and the relative standard deviation was 1.02%.Conclusion TLC and HPLC methods are convenient,fast,accurate,repeatable and special,and can be used to control Shanzhajing Jiangzhi capsule.
Key concepts: Chromatography, Capsule, Ursolic acid, High-performance liquid chromatography, Chemistry, Calibration curve, Quality standard, Formic acid