Simultaneous Determination of Paracetamol, Phenylephrine Hydrochloride, Oxolamine Citrate and Chlorpheniramine Maleate by HPLC in Pharmaceutical Dosage Forms

Abstract

A new high performance liquid chromatographic (HPLC) method was developed for the determination of paracetamol, phenylephrine hydrochloride, oxolamine citrate and chlorpheniramine maleate in combined pharmaceutical formulations and dosage forms. The separation was performed on an Agilent Zorbax SB-CN column with the mobile phase consisting of 0.02 M phosphate buffer (pH:4) and acetonitrile (85:15,v/v) in flow rate 1.5 mL at 22 °C. The overall retention time of the analytes was 3.5 min. The method was validated with respect to linearity, precision, accuracy and recovery. The relative standard deviation for 10 replicate measurements of paracetamol, phenylephrine HCl, oxolamine citrate and chlorpheniramine maleate were 0.12, 0.36 0.18 and 0.59%, respectively. Total recoveries of analytes were 99.99, 100.56, 100.20 and 99.60%, respectively. No chromatographic interference from the tablet excipients was found. The linearity of paracetamol, phenylephrine HCl, oxolamine citrate and chlorpheniramine maleate were in the range of 20-120 μg/mL, 0.4-2.4 μg/mL, 8-48 μg/mL and 0.16-0.96 μg/mL, respectively. This simple, fast, economical and precise high performance liquid chromatographic method can be adopted for routine quality control analysis.