Simultaneous estimation of phenylephrine HCl, chlorpheniramine maleate and dextromethorphan HBr in a pharmaceutical (syrup) formulations by RP-HPLC using PDA detector

Abstract

The present study aimed to develop and validate the simultaneous estimation of phenylephrine HCl, chlorpheniramine maleate and dextromethorphan HBr in tablet dosage forms. A gradient reversed phase high-performance liquid chromatographic (HPLC) method with ultraviolet detection at 220 nm has been developed for the simulataneous determination of phenylephrine HCl, chlorpheniramine maleate and dextromethorphan HBr in pharmaceutical dosage forms (Syrup). Good chromatographic separation was achieved by using a stainless steel analytical column, the Hypersil BDS C8 column (4.6 X 250 mm; 5 μm). The system was operated at 25 ± 2°C using a mobile phase consisted of HPLC grade water (composed of TEA and 1-octane sulfonic acid sodium salt) (pH adjusted to 3.2 using orthophosphoric acid) and acetonitrile, mixed at gradient mode, manitained flow rate at 1.0 mL/minute. The slope, intercept, and correlation coefficient were found to be y = 34306x - 11042 (r2= 0.999) for phenylephrine HCl, y = 35874x - 13101 (r2= 0.999) for chlorpheniramine maleate and dextromethorphan HBr y = 25516x - 26579 (r2 = 0.999), respectively. The proposed method was validated for its specificity, linearity, accuracy, and precision. The method was found to be suitable for the quality control of phenylephrine HCl, chlorpheniramine maleate and dextromethorphan HBr simultaneously in a bulk drug samples as well as in a formulations.