Validated RP-HPLC method for simultaneous determination and quantification of chlorpheniramine maleate, paracetamol and caffeine in tablet formulation.

Chlorpheniramine maleate-paracetamol-caffeine tablet formulation is one of the common over-the-counter drugs used for the treatment of cold and cough. A reversed-phase high-performance liquid-chromatography method has been successfully developed for the simultaneous determination of chlorpheniramine maleate, paracetamol and caffeine in a drug formulation. The RP-HPLC method employed a Phenomenex C18 reversed phase column (Luna 5µ, 250 × 4.6 mm) with an isocratic mixture of methanol and 0.05 M dibasic phosphate buffer pH 4.0 in the ratio of (30:70; v/v) as the mobile phase. The column temperature was kept at 30 °C. The flow rate was 1.0 mL/min and detection was by means of a UV detector at wavelength of 215 nm. All the active components were successfully eluted with mean retention times of 2.4, 4.2, 7.2 min for chlorpheniramine maleate, paracetamol and caffeine respectively. The method was found to be linear (R(2) > 0.99), precise (RSD < 2.0 %), accurate (recoveries 97.9-102.8 %), specific, simple, sensitive, rapid and robust. The validated method can be used in routine quality control analysis of fixed dose combination tablets containing chlorpheniramine maleate, paracetamol and caffeine without any interference by excipients.