Assay of artemether, methylparaben and propylparaben in a formulated paediatric antimalarial dry suspension

Two HPLC–UV methods are described for the separate determination of artemether (AM) and the combined preservatives, methylparaben and propylparaben in a pharmaceutical dosage form. These analytes are contained in a dry suspension with a high amount of non-soluble excipients, some of which can interfere with the analysis. This makes their separation and analysis of the actives complex. Moreover, due to the wide difference in concentrations, the three analytes could not be quantitated simultaneously. Artemether was analysed using a reversed-phase Nucleosil® C18 column [5 μm, 125 mm × 4 mm (i.d.)] with a mixture of acetonitrile: potassium phosphate buffer pH 5.0 (0.05 M): water [48:32:10 (v/v/v)] as mobile phase. Due to the low solubility of the hydroxy benzoic acid esters in water, their sodium salts were used in the formulation. Complete separation of these preservatives was achieved on the same type of column as artemether using as eluent acetonitrile: potassium phosphate buffer pH 5.0 (0.05 M) (30:70, v/v). Quantitation was achieved with UV detection at 215 nm for artemether and 254 nm for the parabens, respectively. And in both methods, pump flow rate was 1.0 ml/min, sample injection volume 20 μl, ambient temperature maintained and no prior sample extraction methods were necessary throughout the experiments. Calibration curves were linear at concentration ranges of 4–16 μg/ml, 1–4 μg/ml and 1–10 mg/ml for methylparaben, propylparaben and artemether respectively. The excipient powder interference could be eliminated by diluting the sample and the analytes eluted at relatively short times using these systems. Both methods were further validated in terms of specificity, linearity, precision and accuracy. The procedures prescribed here are simple, selective and can be used for routine quality control and stability indicating tests involving the analysed compounds formulated in complex matrices.