RP-HPLC method development and validation for the estimation of antifungal drug terbinafine HCL in bulk and pharmaceutical dosage form

Abstract

In the present work RP-HPLC method has been developed for the quantitative estimation of Terbinafine hydrochloride in bulk drug and pharmaceutical formulations. A rapid and sensitive RP-HPLC Method with PDA detection (220 nm) for routine analysis of in Bulk drug and Pharmaceutical formulation was developed. Chromatography was performed with mobile phase containing a mixture of Potassium dihydrogen phosphate and Acetonitrile (65:35 v/v) with flow rate 1.5 ml/min. The linearity was found to be in the range of 50-150 µg/ml with (r2=0.999). The proposed method was validated by determining sensitivity, accuracy, precision, LOD, LOQ and system suitability parameters according to ICH guidrelines.