Development of UV Validated Analytical Methods for Dronedarone Hydrochloride in Tablet Dosage Form and its Application

Abstract

An efficient, accurate, and cost-effective UV-spectrophotometric approach has been established for the quantification of Dronedarone hydrochloride in pharmaceutical formulations. The method employed was the area under the curve (AUC), wherein the area was integrated over the wavelength range of 270 nm to 300 nm. Calibration curves were constructed for the procedure utilizing instrumental responses at designated wavelengths and analyte concentrations in the solution. The detector response exhibited linearity within the concentration range of 2-6 µg/ml for the procedure. The tablet formulation was examined, revealing a drug percentage of in the assays. Studies on accuracy and precision were conducted, yielding satisfactory results. The analysis results were statistically validated. The method's limit of detection and limit of quantitation were established. The approach was validated by adhering to the analytical performance parameters recommended by the International Conference on Harmonization. All validation parameters fell within the permissible range. The devised approach was effectively utilized to quantify the concentration of Dronedarone hydrochloride in pharmaceutical formulations.