DEVELOPMENT AND VALIDATION OF A NEW HPLC-UV METHOD FOR SIMULTANEOUS ESTIMATION OF CETIRIZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE IN TABLET FORMULATION

A simple, rapid, and sensitive high-performance liquid chromatographic method with UV detection has been developed and validated according to the ICH guidelines for the quantitation of Cetirizine Hydrochloride (CET) and Phenylephrine Hydrochloride (PHEN) in the tablet dosage form. Chromatographic separation was carried out in a Zorbax eclipse plus, C18 column (250 mm × 4.6 mm; 5 µm particle size) with simple mobile phase composition of a mixture of Buffer (Water + 0.2% v/v Triethylamine, pH 7.5 by dil. H₃PO₄) and Acetonitrile (63:37 v/v) at a flow rate of 1ml/min and sample injection of 20 µL was injected at 25 ºC. The eluent was monitored with a UV/VIS detector set at 232 nm with a total run time of 15 minutes. The method was linear over the concentration range of 20-100 µg/ml for CET and 40-100 µg/ml for PHEN with a correlation coefficient of 0.999 for both the analytes. Accuracy and precision values of both within-run and between-run were obtained from six different sets of three quality control (QC) samples analyzed on separate occasions for both the analytes ranged from 99.30% to 100.04% and 0.23% to 1.90%, respectively. Extraction recovery of analytes in the pharmaceutical formulation was found to be from 97.34% to 101.74%. The developed and validated method was successfully applied to the quantitative determination of CET and PHEN in a pharmaceutical formulation.