Abstract
A simple, precise and accurate RP-HPLC-PDA method has been developed and validated for the estimation of Chlorpheniramine Maleate, an antihistaminic in bulk and pharmaceutical dosage forms. It is a synthetic first generation alkylamine developed for the treatment of allergic conditions. Chromatography was carried out on an Inertsil C18 (250 x4.6mm, 5μm) column with a mobile phase combination of 10mM Ammonium Acetate and Acetonitrile in the ratio of 40:60v/v. The detection wavelength was carried out at 220 nm. The flow rate is 1.2 ml/min. The retention time is 5.122 minutes. The linearity was found in the range of 5-25μg/ml (r=0.999) and percent RSD is less than 2. The mean recoveries obtained for Chlorpheniramine Maleate were in the range of 98.77-99.42%. The LOD and LOQ values were found to be 0.315μg/ml and 0.949μg/ml. The method was validated as per ICH guidelines and can be applied for quality control analysis of Chlorpheniramine Maleate in bulk and pharmaceutical dosage forms.
