Development and Validation of Analytical Methods for Simultaneous Estimation of Terbinafine and Itraconazole in Bulk and Pharmaceutical Dosage Form.

Abstract

Two new simple, accurate and precise UV-VIS spectrophotometric methods have been developed for simultaneous estimation of Terbinafine and Itraconazole in bulk and pharmaceutical dosage forms. The first method is simultaneous estimation using vierodt's equation where absorption maxima found at 289nm and 282nm for Terbinafine (TER) and Itraconazole (ITZ) respectively. The second method is based on Qmethod / Absorption ratio method using two wavelengths, at 285nm (Isobestic point) and 289nm(λmax for Terbinafine). Two methods follow Beer's linearity in the range of 10-35µg/ml for Terbinafine and 5-30µg/ml for Itraconazole with correlation coefficient r 2 of 0.999 and 0.999 for Terbinafine and Itraconazole,(method 1); 0.999, 0.999 for Terbinafine and 0.999, 0.999 for Itraconazole(method 2). All LOD, LOQ, %RSD are less than 2.According to ICH norms the parameters linearity, precision, accuracy, limit of detection, and limit of quantification, robustness and ruggedness were studied. The proposed methods were simple, cost effective and were successfully applied to the determination of these drugs in quality control of combined pharmaceutical dosage.