DEVELOPMENT OF FIRST ORDER DERIVATIVE ULTRAVIOLET SPECTROPHOTOMETRIC METHOD FOR SIMULTANEOUS ESTIMATION OF LEVOCETIRIZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE IN BULK AND COMBINED DOSAGE FORM

Abstract

The first order derivative method of ultraviolet spectrometry for simultaneous determination of Levocetirizine hydrochloride (LEV) and Phenylephrine hydrochloride (PHE) in bulk drug and combined dosage form was found to be simple, accurate, fast, precise and reproducible. Methanol was used as solvent for the study. The linearity for zero order derivative method was carried out by using the concentration range 3-9 µg/ml for LEV and 6-18 µg/ml for PHE. The coefficient correlation of LEV and PHE for zero order was found to be 0.9993 and 0.9996 respectively. At zero crossing point of LEV (230nm) PHE showed a measurable derivative absorbance where as at the zero crossing point of PHE (216nm), LEV showed appreciable derivative absorbance value. Precision study showed that % RSD was within the range of acceptable limits (<2). The % recovery for LEV and PHE was found to be in the range of 98-100% and 100-102% respectively and in the marketed formulation PHE and LEV was found as 99.19% and .99.88% respectively. The developed method was validated as per ICH Q2 (R1) guidelines and results obtained with a high percentage of recovery, good accuracy and precision.