Development and Validation of New Analytical Methods for Simultaneous Estimation of Cetrizine Hydrochloride and Phenylephrine Hydrochloride in Pharmaceutical Dosage Form

Abstract

Reversed-phase HPLC and UV spectrophotometric techniques have been developed and validated for the simultaneous determination of Cetrizine hydrochloride and Phenylephrine hydrochloride in synthetic mixture and its combined dosage form. The first method was based on UV-spectrophotometric determination of two drugs using Vierordt!s simultaneous equation method. This employs formation and solving of mathematical simultaneous equation using 272.8 nm and 230.83 nm as the λmax of phenylephrine hydrochloride and cetirizine hydrochloride respectively in 0.1 N NaOH. Linearity was obtained in the range of 10-50 μg/ml for both the drugs at selected wavelengths, correlation coefficient (r2 <1). The second method was based on RP-HPLC separation was achieved on C18 column ( Intersil, 220 mm × 4.6 mm i.d., 10 μm particle size) at ambient temperature using disodium hydrogen phosphate (Na2HPO4) buffer; pH was adjusted to 6.50 using ortho-phosphoric acid and a mobile phase of Methanol : Acetonitrile : Disodium hydrogen phosphate (80 : 3 : 17, v/v ) at flow rate 2.0 ml/min. Quantification was achieved with series 200 UV/ Visible detector, series 200 pump, series 200 vacuum degasser, and chromatography interface 600 series link at wavelength 272 nm. The retention time was found to be 1.2 ± 0.04 min and 3.1 ± 0.06 min for cetirizine HCl & phenylephrine HCl respectively. The calibration curves were linear with correlation coefficient 0.998 and 0.999 in the range of 10-50 μg/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.