HPLC METHOD DEVELOPMENT AND VALIDATION FOR THE SIMULTANEOUS ESTIMATION OF ITRACONAZOLE AND TERBINAFINE IN BULK AND PHARMACEUTICAL DOSAGE FORM

A simple, Accurate, precise method was developed for the simultaneous estimation of the Terbinafine and Itraconazole in bulk and pharmaceutical dosage form. Chromatogram was run through phenomenex C18 150 x 4.6mm, 5.0m. Mobile phase containing Buffer 0.1%OPA: Methanol taken in the ratio 60:40v/v was pumped through column at a flow rate of 1.0ml/min. Temperature was maintained at 30°C. Optimized wavelength selected was 245 nm. Retention time of Terbinafine and Itraconazole were found to be 2.331 min and 2.934 min. %RSD of the Terbinafine and Itraconazole were and found to be 0.4 and 0.9 respectively. %Recovery was obtained as 99.95% and 100.98% for Terbinafine and Itraconazole respectively. LOD, LOQ values obtained from regression equations of Terbinafine and Itraconazole were 0.94, 2.86 and 0.70, 2.13 respectively. Regression equation of Terbinafine is y =  6951.x + 2494., and y = 7657x + 2075. of Itraconazole Retention times were decreased and that run time was decreased, so the method developed was simple and economical that can be adopted in regular Quality control test in Industries.

Key Words: Terbinafine, Itraconazole, RP-HPLC