Simultaneous determination of antihistamine anti-allergic drugs, cetirizine, domperidone, chlorphenamine maleate, loratadine, meclizine and buclizine in pharmaceutical formulations, human serum and pharmacokinetics application

Abstract

This article describes a new, accurate and highly specific high performance liquid chromatographic method with UV detection (HPLC-UV) for the simultaneous determination of cetirizine HCl (CZ), chlorphenamine maleate (CPM), loratadine (LTD), domperidone (DP), buclizine (BZ) and meclizine (MZ) in pharmaceutical dosage form and human serum, involving pyridoxine (PYD) as the internal standard. The mobile phase consists of heptane sulphonic acid salt buffer and acetonitrile, drawn at a flow rate of 1.0 mL min⁻¹ using a symmetry C₁₈ column with UV detection at 230 nm. The intraday and inter-day precision measurements showed coefficients of variation always less than one. The calibration curve was tested in the range of 10–2150 ng mL⁻¹ and the correlation coefficient of >0.9990 in all cases was obtained. The averages of the absolute and relative recoveries were found to be in the range of 98 to 102%. Up to six antihistamines were separated in the same chromatogram with good resolution. The proposed HPLC method has reasonable applications in pharmaceutical tablet dosage form and pharmacokinetics studies.