Ion-Pair High-Performance Liquid Chromatographic Determination of Chlorpheniramine Maleate in Cough-Cold Mixtures

A high-performance liquid chromatographic method in the ion-pair mode was developed for the assay of chlorpheniramine maleate in commercial cough-cold mixtures. The method uses a µ Bondapak phenyl column and a mixture of acetonitrile-acetic acid-water (26.5:1.0:72.5, by volume, pH 2.4) containing 0.005M pentanesul-fonic acid sodium salt as the mobile phase. Chlorpheniramine maleate was well resolved from ten other active ingredients. A linear relationship was obtained between detector response at 254 nm and amounts of chlorpheniramine maleate injected ranging from 0.8 to 2.5 µg(r=0.996). A reproducibility study using a standard preparation gave a CV of 1.43% (n = 10). The average recovery values of chlorpheniramine maleate added in various amounts to a single-component tablet composite sample and to a multiple-component tablet composite sample were 99.1 and 100.9%, respectively. The assay of commercial tablets by the proposed method gave results which differed by 0.7 to 3.2% of declared from those obtained by the method of USP XX.