Simultaneous Determination of Three Components in Ganmao Shufeng Tablets by HPLC
Objective To establish a high-performance liquid chromatography(HPLC)method for determining the contents of ephedrine hydrochloride,pseudoephedrine hydrochloride and D-amygdalin in Ganmao Shufeng Tablets.Methods The chromatographic column was Agilent Phenyl-Hexyl column(250 mm×4.6 mm,5 μm),the flow rate was 1.0 mL/min,the detection wavelength was 210 nm,and the injection volume was 10 μL.The mobile phase of ephedrine hydrochloride and pseudoephedrine hydrochloride was 0.02 mol/L potassium dihydrogen phosphate aqueous solution(containing 0.2%triethylamine,adjusting to pH 3.5 with phosphoric acid)-acetonitrile(98∶2,V/V),and the column temperature was 40℃;the mobile phase of D-amygdalin was acetonitrile-water(5∶95,V/V),and the column temperature was 30℃.Results The linear ranges of ephedrine hydrochloride,pseudoephedrine hydrochloride and D-amygdalin were 4.166-104.15 μg/mL(r=0.999 9),4.210-105.250 μg/mL(r=0.999 9),22.40-224 μg/mL(r=0.999 9)respectively.The RSDs of precision,stability and repeatability tests were all lower than 2.0%.The average recovery rates of the above three components in film-coated tablets were 98.62%,98.40%,99.52%,with RSDs of 1.45%,1.50%,1.24%(n=6)respectively;those in ordinary tablets were 99.26%,98.63%,99.63%,with RSDs of 1.25%,1.12%,0.90%(n=6)respectively.Conclusion The established method is simple,accurate,precise,stable,and repeatable,which can be used for the determination of ephedrine hydrochloride,pseudoephedrine hydrochloride and D-amygdalin in Ganmao Shufeng Tablets.