Determination of Ephedrine Hydrochloride and Pseudoephedrine Hydrochloride Contents in Xiao'er Qingre Zhike Granules by HPLC

OBJECTIVE To establish a HPLC method for the determination of ephedrine hydrochloride and pseudoephedrine hydrochloride contents in Xiao'er Qingre Zhike granules. METHODS Separation was performed on ZORBAX SB C₁₈ column. 0.1% phosphoric acid solution-acetonitrile(96∶4) was selected as the mobile phase, flow rate was set at 1.0 mL·min^-1 and detection wavelength was 205 nm. RESULTS The linear range for ephedrine hydrochloride was 4.388-43.88 μg·mL^-1(r=0. 999 9), the average recovery of ephedrine hydrochloride was 99.7%, RSD=2.1% (n=6). The linear range for pseudoephedrine hydrochloride was 5.300-53.00 μg·mL^-1(r=0.999 7), the average recovery of pseudoephedrine hydrochloride was 98.5%, RSD=2.8%(n=6). CONCLUTION The method is accurate and repeatable, and it can be applied to control the quality of this drug.