Development and validation of a HPLC method for the determination of cetirizine in pharmaceutical dosage forms.

A rapid, simple and accurate HPLC method is described for the assay of cetirizine in commercial dosage forms. Methanol was found to be a suitable extraction solvent for tablets and for preparing solutions from drops and oral liquids. The samples were chromatographed on a Nova-Pak C18 column and UV detected at 227 nm. The elution was achieved isocratically with a mobile phase of 0.067 M phosphate buffer pH 3.40/acetonitrile (1:1, v/v). Ketotifen was applied as an internal standard. The method was validated for linearity, precision, accuracy and limit of detection. The recovery (mean +/- SD) for tablets was 100.88% +/- 0.8967, for drops 100.35% +/- 0.4062 and for solutions 101.20% +/- 1.1698.