Vol. 6, Issue 3 (2017)

Author(s):
Imad Osman Abu Reid and Elrasheed Ahmed Gadkariem

Abstract:
A simple and efficient liquid chromatographic method has been developed and validated for the simultaneous determination of pseudoephedrine (PS) and loratadine (LOR) in syrup dosage form. The separation was achieved within 7.0 min, employing a mixture of 53.5% v/v water-methanol containing 30.12 mM/L sodium dihydrogen orthophosphate adjusted to pH 5.22 as isocratic mobile phase, pumped at 1.0 ml/min through a strong cation exchange column (10µm particle size). The analytes were detected at 254 nm. Statistical experimental designs and graphic representations (response surface methodologies, Pareto charts) were used for optimizing the mobile phase composition. The linearity of the calibration (r>0.99, n =15) in the relevant ranges (up to 125% of the expected concentrations of the analytes in the formulation), method accuracy (RSD <2.0%), repeatability (RSD <2.0%) and intermediate precision, were verified. System suitability parameters were also determined. The validated method was successfully employed for the routine analysis of a syrup pharmaceutical preparation.