A NOVEL HPLC METHOD FOR THE SIMULTANEOUS DETERMINATION OF CHLORPHENIRAMINE MALEATE AND DEXTROMETHORPHAN IN BULK AND PHARMACEUTICAL FORMULATION

Chlorpheniramine maleate and Dextromethorphan are used in treatment of cough caused by allergies and the common cold by decreasing intra ocular pressure. The present study was designed to develop and validate a simple, sensitive, precise and accurate reverse phase high performance liquid chromatographic (HPLC) method for simultaneous determination of Chlorpheniramine maleate and Dextromethorphan in tablet dosage form. Chromatographic separation of these two drugs was achieved on Discovery C18 column (250 x 4.6 mm, 5 μm) as stationary phase with a mobile phase of Water (pH 2 adjusted with OPA): Acetonitrile (60:40v/v)  at a flow rate of 1 ml/min and PDA detection at 218 nm. The retention times of Chlorpheniramine maleate and Dextromethorphan were found to be 3.0 min and 3.6 min respectively. The proposed method was validated for system suitability, linearity, accuracy, precision, LOD, LOQ and robustness. The calibration curves were linear in the concentration range of 50% to 150% of the working concentration (r² = 0.999) for both the drugs in binary mixture. The LOD was found to be 0.04 μg/ml and 0.11 μg/ml and LOQ was found to be 0.14 μg/ml and 0.43 μg/ml for Chlorpheniramine maleate and Dextromethorphan respectively. Hence the proposed RP-HPLC method can be used in routine analysis of tablets containing Chlorpheniramine maleate and Dextromethorphan.