SIMULTANEOUS DETERMINATION OF ITRACONAZOLE AND TERBINAFINE IN PHARMACEUTICAL DOSAGE FORMS BY RP-HPLC

Abstract

A simple, accurate, and precise reverse-phase high-performance liquid chromatography (RP-HPLC) method was developed for the simultaneous estimation of Itraconazole and Terbinafine in tablet dosage forms. Chromatographic separation was achieved using a Syncronis C18 column (150 mm × 4.6 mm, 5 μm) with a mobile phase consisting of 0.01N KH₂PO₄ buffer (pH 4.8) and acetonitrile in the ratio of 35:65 (v/v), at a flow rate of 1 mL/min and a column temperature of 25°C. The detection wavelength was set at 237 nm. The retention times for Itraconazole and Terbinafine were found to be 2.2 min and 3.2 min, respectively. The method showed excellent linearity, accuracy, and precision, with %RSD values of 1.2 and 0.5, and recovery rates of 99.95% and 99.89% for Itraconazole and Terbinafine, respectively. The method is suitable for routine quality control analysis of these drugs in pharmaceutical formulations.