DEVELOPMENT AND VALIDATION OF A PRECISE RP-HPLC METHOD FOR SIMULTANEOUS ANALYSIS OF FEXOFENADINE HYDROCHLORIDE AND CETIRIZINE HYDROCHLORIDE IN COMBINED TABLET FORMULATION

Vignesh S.*, Kalaiselvi Ponnusamy, Senthilkumar Natesan and Kathiravan Natarasan K.

ABSTRACT

A precise RP-HPLC method was established and validated for the analysis of a combined tablet formulation containing Fexofenadine hydrochloride and Cetirizine hydrochloride. The study employed a SHIMADZU-1 SERIES LC-2030 system with a Phenomenex Luna C18 100A;1 stationary phase (50mm X 4.6mm). The mobile phase, consisting of 30% ACN, 20% methanol, and 50% pH 3.0 buffer, was held constant in an isocratic manner. The flow rate remained at 1.0 mL/min, and each injection volume was 20 microliters, with detection occurring at 230nm. The RP HPLC analysis yielded distinct separation of peaks corresponding to Fexofenadine hydrochloride and Cetirizine hydrochloride in just 10 minutes. Retention times were measured at 4.121 and 5.72S minutes for Fexofenadine hydrochloride and Cetirizine hydrochloride, respectively. Noteworthy was the high column efficiency, with Fexofenadine hydrochloride having 1,751,807 theoretical plates and Cetirizine hydrochloride having 303,378 theoretical plates, attesting to the column's strong performance. A resolution of 3.976 highlighted the clear distinction between the peaks. The quantitative analysis of the formulated tablet indicated robust method accuracy, showing Fexofenadine hydrochloride at 99.58% and Cetirizine hydrochloride at 99.62%. This method demonstrates its suitability for accurately and reliably determining the presence and quantity of these active pharmaceutical ingredients in the combined tablet dosage form

Keywords: RP-HPLC, Fexofinadine hydrochloride, Cetirizine hydrochloride, Retention time, run time, Buffer, ACN, Methanol..