Simultaneous analysis of ambroxol HCl with cetirizine HCl and of ambroxol HCl with levo -cetirizine dihydrochloride in solid dosage forms by RP-HPLC
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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 H 1 blockers. Chromatography was performed on a 250 mm × 4.6 mm, 5-µm particle size, C 18 (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.
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