Development and validation of the UVspectrophotometric method for determination of terbinafine hydrochloride in bulk and in formulation

摘要

Background: The main objective was to develop and validate the UV-spectrophotometricmethod for the estimation of terbinafine hydrochloride in bulk and pharmaceuticalformulations as per ICH guidelines Materials and Methods: A simple, rapid, accurate,and economical UV-spectrophotometric method has been developed for the estimation ofterbinafine hydrochloride from bulk and pharmaceutical formulation. Results: The λmax ofterbinafine hydrochloride in water was found to be 283 nm. The drug follows linearity in theconcentration range 5–30 μg/ml with a correlation coefficient value of 0.999. The proposedmethod was applied to pharmaceutical formulation and % amount of drug. estimated was99.19% and was found to be in good agreement with the label claim. The accuracy of themethod was checked by recovery experiment performed at three different levels, i.e., 80%,100%, and 120%. The % recovery was found to be in the range of 98.54– 99.98%. The low valuesof % RSD are indicative of the accuracy and reproducibility of the method. The precision of themethod was studied as an intraday; interday variations, and repeatability. The % RSD value< 2 indicates that the method is precise. Ruggedness of the proposed method was studiedwith the help of two analysts. Conclusion: The above method was a rapid tool for routineanalysis of terbinafine hydrochloride in the bulk and in the pharmaceutical dosage form.