Simultaneous estimation of Cetrizine hydrochloride and Phenylephrine hydrochloride in tablet dosage form by RP-HPLC

Abstract

A simple, economical, specific, accurate, precise and validated Reverse phase high performance liquid chromatography (RP-HPLC) method has been developed for the simultaneous estimation of Cetrizine hydrochloride and Phenylephrine hydrochloride in synthetic mixture and its combined dosage form. The chromatographic separation was achieved on C18 column (Intersil, 220 mm 4.6 mm i.d., 10 ?m particle size) at ambient temperature using disodium hydrogen phosphate (Na ₂ HPO ₄ ) buffer; pH was adjusted to 6.50 using ortho-phosphoric acid and a mobile phase of Methanol: Acetonitrile: Disodium hydrogen phosphate (80: 4: 19, v/v) at flow rate 2.0 ml/min. Quantification was achieved with UV detector at wavelength 270 nm. The retention time was found to be 1.2 0.04 min and 3.1 0.06 min for cetirizine HCl and phenylephrine HCl respectively. The calibration curves were linear with correlation coefficient 0.998 and 0.999 in the range of 10-50 ?g/ml for Cetrizine hydrochloride and Phenylephrine hydrochloride. The methods were validated in terms of linearity, precision, accuracy, LOD, LOQ and ruggedness according to ICH guideline.