Original Articles: 2021 Vol: 13 Issue: 5
UV-Spectrometric Method Development and Validation of Tavaborole
Abstract
There is a need to develop a reliable, cost effective, and methodologies for a routine analytical method of active pharmaceutical ingredients being an essential part of pre-formulation, formulation research and development. A new, economical, sensitive, simple, rapid UV spectrophotometric method has been developed for the estimation of Tavaborole in pure form. Tavaboroleis an antifungal agent formulated for the treatment of toenail onychomycosis. This UV method was developed using methanol as a solvent. Tavaborole has shown absorption maxima at 272 nm and 265 nm in all the methods. UV-Visible double beam spectrophotometer (Jasco V-730) was used to carry out the spectral analysis.The ICH guidelines were used to validate the method. The method was validated for linearity, accuracy, precision, robustness, ruggedness, LOD and LOQ. Beer’s law was obeyed over the concentration range of 20-100 μg/ml, using regression analysis. The linear equation y=0.0049x+0.0024, y=0.0054x-0.0026 with a correlation coefficient of R²=0.9981, R²=0.9979 at wavelength 272 nm and 265 nm respectively was obtained. The limit of detection was found to be 103.749 μg/mL, 105.289 μg/mL and the limit of quantification was found to be 314.392 μg/mL, 319.058 μg/mL at 272 nm and 265 nm respectively. Precision was calculated with intra and interday variation. Recovery study was performed on formulations and % RSD value was found to be less than 2. The proposed UV spectroscopic method was found to be linear, accurate, precise, stable, specific and simple for quantitative estimation. Hence the present UV spectroscopic method is suitable for the routine assay of tavaborole in bulk and pharmaceutical formulations.