Development and validation of the UV-spectrophotometric method for determination of terbinafine hydrochloride in bulk and in formulation

BACKGROUND The main objective was to develop and validate the UV-spectrophotometric method for the estimation of terbinafine hydrochloride in bulk and pharmaceutical formulations as per ICH guidelines. MATERIALS AND METHODS A simple, rapid, accurate, and economical UV-spectrophotometric method has been developed for the estimation of terbinafine hydrochloride from bulk and pharmaceutical formulation. RESULTS The λmax of terbinafine hydrochloride in water was found to be 283 nm. The drug follows linearity in the concentration range 5-30 μg/ml with a correlation coefficient value of 0.999. The proposed method was applied to pharmaceutical formulation and % amount of drug. estimated was 99.19% and was found to be in good agreement with the label claim. The accuracy of the method 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 values of % RSD are indicative of the accuracy and reproducibility of the method. The precision of the method 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 studied with the help of two analysts. CONCLUSION The above method was a rapid tool for routine analysis of terbinafine hydrochloride in the bulk and in the pharmaceutical dosage form.