A novel, simple and cost-efficient gradient RP-HPLC method was developed for the simultaneous analysis of phenylephrine hydrochloride (PE) and Chlorpheniramine maleate (CM) within the marketed formulation. A reverse-phase C18 column (Intersil ODS-3V; particle size 5 μm 4.6*250mm) with mobile phase A consisting of potassium dihydrogen phosphate (pH 3.5 adjusted with ortho phosphoric acid), and mobile phase B consisting 100% Acetonitrile was used. The flow rate was 1.0 ml/min and effluents were monitored at 225 nm. The retention times of Phenylephrine hydrochloride and Chlorpheniramine maleate were found to be 3.75 min and 17.47 min respectively. The method was validated in terms of linearity, specificity, accuracy, precision, robustness and forced degradation. The percentage recoveries of Phenylephrine hydrochloride and Chlorpheniramine maleate were found to be 99.8 and 99.3. The developed method was successfully applied for the simultaneous analysis of adrenergic drug and chlorpheniramine in a tablet dosage form.

Varsha. S. Dhanawade, Dr. Nutan Rao

Phenylephrine hydrochloride; Chlorpheniramine maleate; simultaneous analysis; RP-HPLC; tablet dosage form.