Quality Standard for Ehong Capsules / 中国药师

ABSTRACT

Objective: To establish the quality standard for Ehong capsules.Methods: A TLC was adopted to identify safflower, pueraria and prepared Radix Polygoni Multiflori.The contents of hydroxyl-safflor yellow A and puerarin in Ehong capsules were determined by a dual wavelength HPLC.A Wondasil C 18-WR (250 mm× 4.6 mm ,5 μm) was used as the analytical column, the mobile phase was composed of methanol acetonitrile-0.7% phosphoric acid aqueous solution (16∶3∶81), the flow rate was 1.0 ml·min-1 ,the detection wavelength was 403 nm for hydroxy safflower yellow A and 250 nm for puerarin.The column temperature was 30℃.Results: The TLC spots were clear and well-separated without negative interference.The calibration curves of hydroxyl-safflor yellow A and puerarin were linear over the ranges, the average recovery was 101.02% and 100.03% , and the RSD was 1.43% and 2.40% (n =6), respectively.Conclusion: The method is fast and accurate with good specificity, which can be used for the quality control of Ehong capsules.