Simultaneous analysis of ambroxol HCl with cetirizine HCl and of ambroxol HCl with<i>levo</i>-cetirizine dihydrochloride in solid dosage forms by RP-HPLC

Abstract

An isocratic RP-HPLC method has been developed and validated for simultaneous analysis of ambroxol hydrochloride (AMB) with cetirizine hydrochloride (CTZ) and of ambroxol hydrochloride (AMB) with levo-cetirizine dihydrochloride (LCTZ) in combined solid dosage forms. Formulations containing AMB with CTZ (tablets) and AMB with LCTZ (capsules) are used as antihistaminic H1 blockers. Chromatography was performed on a 250 mm × 4.6 mm, 5-μm particle size, C18 (ODS) column with a 45:30:30 (v/v) mixture of 30 mM aqueous ammonium sulphate (pH 5.5), acetonitrile, and methanol as mobile phase at a flow rate of 1 mL min−1. The detection wavelength was 230 nm and analysis was performed at room temperature. Hydrochlorothiazide was used as internal standard for both formulations. Plots of drug-to-internal standard peakarea ratios (response factor) against respective concentrations were linear in the range 3 to 20 μg mL−1 for AMB and in the range 1 to 11 μg mL−1 for CTZ and LCTZ. The method was precise (RSD < 2) and accurate for analysis of both drugs in pharmaceutical dosage forms. Statistical data and results from recovery studies were reported for both formulations.