Vol. 14, Issue 11 (2025)

The goal of this study was to create and confirm a method for accurately measuring terbinafine HCl in both raw material and tablet forms using a UV-Visible spectrophotometer and reversed-phase high-performance liquid chromatography (HPLC). The method is straightforward, precise, accurate, and consistent. The UV-Visible technique relied on measuring the absorbance of terbinafine HCl at 282 nm using a Systronic AU-2702 double-beam UV-Visible spectrophotometer. The separation process was carried out using a Shimadzu SPD-10A column (250×4.6 mm, 5 µm), with a 3.9 mm inner diameter, of the C18 type. The mobile phase consisted of methanol, acetonitrile, and phosphate buffer at pH 5, in a ratio of 80:10:10 (v/v), with a flow rate of 1.2 mL/min. The column was kept at room temperature, and the detector was set to 282 nm. The retention time for terbinafine HCl was 8.7 minutes, with a total run time of 10 minutes. The method was evaluated for parameters like system suitability, specificity, linearity, precision, accuracy, robustness, and ruggedness. The low RSD values confirmed the method's accuracy and precision, making it suitable for quantifying terbinafine HCl in drug products. These methods are appropriate for routine quality control testing of finished drug products, as they are free from interference by other components.