Area Under Curve Method Development And Validation For Estimation Of Dronedarone In Bulk And Tablet Dosage Form

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DOI: 10.4103/2231-4040.197331

A simple, precise and economical UV - spectrophotometric method has been developed for the estimation of Dronedarone in pharmaceutical dosage form. Method applied was area under curve (AUC) in which area was integrated in the wavelength range of 270.40 nm – 300.0 nm. Calibration curves were plotted for the method by using instrumental response at selected wavelengths and concentrations of analyte in the solution. Linearity for the detector response was observed in the concentration range of 4-24 µg/ml for the method. Tablet formulation was analyzed and the percentage of drug determined in the assays was 98.00% – 102.00%. Accuracy and precision studies were carried out and results were satisfactory. The results of the analysis were validated statistically. Limit of detection and limit of quantitation were determined for the method. The method was validated by following the analytical performance parameters suggested by the International Conference on Harmonization. All validation parameters were within the acceptable range. The developed method was successfully applied to estimate the amount of Dronedarone in pharmaceutical formulation.

Keywords: Dronedarone, UV-spectrophotometry, Area Under Curve, Validation.