Development and Validation of Stability Indicating RP-HPLC Method for Dronedarone

Abstract

A new, simple, accurate, precise, rapid and selective stability indicating Reverse- Phase High Performance liquid chromatography (RP-HPLC) method has been developed and validated for quantification of dronedarone. The method was based on reverse phase chromatography using Waters SymmetryShield 100×4.6mm, 3.5μ particle size column. The separation in all the degradation peaks were achieved by using gradient elution of 0.05%TFA in Water(Mibile phase A) and 0.05% TFA in ACN (mobile phase B) at flow rate1.0 mL/min and UV detection at 289 nm with the total run time of 30 min, Injection Volume of 10μl and diluent ACN :Water. The column was maintained at 30°C throughout the analysis. Stability indicating capability was established by forced degradation experiment of Dronedarone to acid, alkali, neutral, oxidative, thermal and photodegradation conditions according to ICH guidelines. The peaks of Dronedarone and degradation products were found to be very pure with complete resolution. The Dronedarone was succeptible to degrade in acidic,alkaline and oxidative, neutral conditions. The rate of degradation was as following condition: Alkali > Oxidative > Acid > Neutral degradation. The linear regression analysis data for the calibration plots showed a very good linear relationship with concentration range of 100-700 μg/ml with the linearity equation of y = 93515x + 60152 (r2= 0.9999).The method was validated for System suitability, precision, linearity, and robustness, limit of detection and limit of quantification as per ICH guidelines. The limit of detection and quantitation were found to be 0.1 μg/ml and 0.25 μg/ml, respectively. Therefore the developed RP-HPLC Method can be applied for the estimation of Dronedarone.