Simultaneous Determination of Two Components in Chlorphenamine Maleate and Ephedrine Nasal Drops by HPLC / 中国药师

ABSTRACT

Objective:To establish a method for the simultaneous determination of chlorphenamine maleate and ephedrine hydro-chloride in chlorphenamine maleate and ephedrine nasal drops by HPLC. Methods:An HPLC method was performed on a column of Purospher STAR RP18(150 mm × 4. 6 mm,5 μm)with the mobile phase of acetonitrile -potassium dihydrogen phosphate buffer(pH 3. 0 ± 0. 1)(1882 v/v)at the detection wavelength of 210 nm(adjusting the flow rate and column temperature to 1. 0 ml·min-1 and 35℃,respectively). The injection volume was 20 μl. Results:A good linear relationship was established between the peak response and the concentration of ephedrine hydrochloride and chlorphenamine maleate over the range of 19. 81-118. 85μg·ml-1(r=0. 999 6) and 6. 21-37. 25 μg·ml-1(r=0. 999 8),respectively. The mean recovery of ephedrine hydrochloride and chlorphenamine maleate was 100. 39%(RSD=0. 69%,n=9)and 100. 11%(RSD=0. 60%,n=9),respectively. Conclusion:The proposed method shows high repeatability,good durability and promising accuracy. It can be employed for the determination of two components in chlorphena-mine maleate and ephedrine nasal drops.