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 λ(max) 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.