Development of Novel Method for Determination of Phenylephrine Hydrochloride and Cetirizine Hydrochloride in Tablet Dosage Form using RP-HPLC

Abstract

The literature survey shows that only single complicated method with multiple components of mobile phase is present for the simultaneous determination of phenylephrine hydrochloride and cetirizine hydrochloride in tablet dosage forms. An effort was made to develop a simple, efficient, less time consuming, economic and accurate reverse phase high performance liquid chromatographic method. An Xtera C-8 column (150mm x 4.6mm i.d., particle size 3.5µ) with mobile phase containing methanol: water 85:15 (v/v) with flow rate of 1.2mL/ min was used and effluents were monitored at 230nm. The retention times of phenylephrine hydrochloride and cetirizine hydrochloride were found to be 2.57 and 3.22 min, respectively as compared to 2.20 and 4.16 min in existing conventional method. The linearity was in the range of 5-35μg/mL for both drugs. The limit of detection and limit of quantification were found to be 0.5 and 1.5µg/mL for phenylephrine hydrochloride and 0.3 and 1.0µg/mL for cetirizine hydrochloride respectively. The % recoveries were found to be in the range of 99.82±0.85 and 100.86±1.54 for phenylephrine hydrochloride and cetirizine hydrochloride. The intermediate precision data was also subjected to statistical analysis (F-test and t-test at 95% confidence level). The proposed method was validated and successfully applied to the estimation of phenylephrine hydrochloride and cetirizine hydrochloride in combined tablet dosage forms. 

Keywords: Phenylephrine hydrochloride, Cetirizine hydrochloride, RP-HPLC, Simultaneous determination, ICH