Study on Quality Control of Compound Yixintong Orally Disintegrating Tablets
Objective To establish a method to determine the content of the main active ingredient,pectin glucoside(PG)and pectin rhamnoside(PR),in hawthorn leaf extract in compound Yixintong orally disintegrating tablets.Methods The contents of PG and PR in hawthorn leaf extract were determined by high-performance liquid chromatogra-phy(HPLC),the chromatographic column used Diamonsil C1 8,and the mobile phase was tetrahydrofuran-acetonitrile-methanol-acetate-water(38∶3∶3∶4∶152),the detection wavelength was 330nm,the column temperature was 30℃,and the injection amount was 20 μL.Results PG had a good linear relationship in the concentration range of 0.40-8.00 μg/ml(r=0.999),PR had a good linear relationship in the concentration range of 1.50-30.00 μg/ml(r=0.999);the relative standard deviation(RSD)of precision,repeatability and stability test results were all less than 2.00％;the average recovery rate of PG was 99.40％,RSD was 1.21％(n=6),and the average recovery rate of PR was 99.61％,RSD was 0.52％(n=6).Conclusion The HPLC method in this study has strong specificity,good reproducibility and accurate results,which can be used for quality control of compound Yixintong orally disintegrating tablets.
NETL
NSTL
万方数据
