CHEMOMETRIC APPROACH FOR RP-HPLC DETERMINATION OF DRONEDARONE USING RESPONSE SURFACE METHODOLOGY

The present study depicts the assessment of class III antiarrhythmic drug dronedarone in its drug substance and drug product. Response surface randomized central composite quadratic design has been employed for the optimization of method parameters using reverse-phase high-performance liquid chromatography (RP-HPLC) on Kromasil C18 250 × 4.6 mm, 5 µ with UV detection at 289 nm. The ranges of the independent variables used for the optimization were flow rate 0.9 to 1.1, column temperature 28 °C to 33 °C and composition of buffer in the mobile phase is 55 to 65%. The influence of these independent variables on the output responses: retention time, asymmetric factor, theoretical plates, plate height and capacity factor were evaluated. The five responses were simultaneous optimized by using central composite design. Optimum conditions chosen for the assay were flow rate of 0.945 ml/min, temperature 31.3 °C and buffer: Acetonitrile has taken in the ratio 61.93: 38.07 respectively. The retention time of dronedarone is 2.356 minutes with the employment of the optimum conditions given by the design experiments. All the system suitability parameters were satisfied. Further the method has been validated by the regulatory guidelines framed by the ICH. The method was found linear in the concentration range of 25-150 µg/mL with a regression coefficient of 0.999. The limit of detection and limit of quantification were found to be 0.58 µg/mL and 1.75 µg/mL respectively. The method was found to be simple, linear, accurate, precise and robust. Therefore, it can be used for routine quality control of dronedarone in its tablet dosage form.