Development and Validation of Determination for Chlorpheniramine Maleate, Phenylephrine Hydrochloride and Ibuprofen in Bulk and Pharmaceutical Formulation by Rp-HPLC Method

Abstract

A simple, precise and accurate isocratic RP-HPLC method was successfully developed for the simultaneous determination of chlorpheniramine maleate (CPM), phenylephrine hydrochloride (PHE) and ibuprofen (IBU) in bulk and pharmaceutical preparation. The separation of the drugs was achieved using Inertsil ODS C18 column with mobile phase consisting of methanol and 0.1% triethylamine (55:45 V/V) in water, pH 3 (adjusted with orthophosphoric acid). These drugs were resolved successfully with retention time of 3.0 min for CPM, 4.6 min for PHE and 18.9 min for IBU, when the eluate was monitored at 240 nm. Linearity was found in the concentration range of 10 to 50 μg mL-1 for CPM, 25 to 125 μg mL-1 for PHE and 100 to 500 μg mL-1 for IBU, with a correlation coefficient (r2) of 0.9987, 0.9965 and 0.9998 for CPM, PHE and IBU, respectively. Thus, the proposed method can be successfully applied to the pharmaceutical preparation containing the above mentioned drugs without any interference of excipients.