Am. Mansour, DETERMINATION OF PSEUDOEPHEDRINE HYDROCHLORIDE AND CARBINOXAMINE MALEATE IN COMBINATION-DRUG FORMULATION BY LIQUID-CHROMATOGRAPHY, Journal of AOAC International, 81(5), 1998, pp. 958-962
An isocratic, reversed-phase liquid chromatographic (LC) method was de
veloped for simultaneous determination of pseudoephedrine hydrochlorid
e (I) and carbinoxamine maleate (II) in a pharmaceutical dosage form.
Analysis was conducted on a CN column (10 mu m), with a mobile phase c
onsisting of acetonitrile-methanol-phosphate buffer (pH 5.3)-water (14
0 + 170 + 40 + 100) and at a detection wavelength of 262 nm. The metho
d was validated for linearity, precision, system reproducibility, and
accuracy. Recoveries at 80-120% of labeled claim ranged from 97.4 to 1
00.7% and from 98.5 to 100.2% for I and II, respectively. Results were
linear (correlation coefficient, r > 0.9995 for I in the range 250-75
0 mu g/mL and r > 0.9999 for II in the range 20-60 mu g/mL).