A simple, sensitive, accurate, precise, economic and reproducible UV-Spectrophotometric method for the analysis of Terbinafine HCl in bulk and formulations. The proposed method is validated in accordance with USP and ICH guidelines to check its suitability for the intended analytical application.The method involved estimation of Terbinafine HCl in bulk and formulations using citrate buffer pH 3.0 and Methanol in the 1:1 ratio. Linear response for Terbinafine hydrochloride was observed in the concentration range of 12.50 – 50.00 µg/ml. The correlation coefficient (R2) was found to be 0.9999. This indicates that 99.99% of variation in response is explained by variation in drug concentration. Low values of standard deviation and the % RSD indicates high precision of proposed methods. % Recovery of formulation was done by standard addition method. % Recovery of both the methods i.e., API and formulation lies close to the theoretical value 100 which indicates high accuracy of the proposed methods. From the linearity and accuracy studies, the range of analytical methods for the assay of Terbinafine hydrochloride API and formulation found to be 80% -120% of test concentration. High value of molar absorbtivity and low value of Sandell sensitivity indicates high sensitivity of proposed methods. The proposed UV Spectrophotometric method was found to be new, simple, sensitive, accurate, precise and economic analytical method for the determination of Terbinafine hydrochloride from its bulk drug and pharmaceutical formulations.
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