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Development of a Validated Stability-Indicating RP-HPLC Method for Dronedarone Hydrochloride in Pharmaceutical Formulation

Bhatt KK, Emanual Michael Patelia and Ishani Amin

A simple, precise, rapid, selective, and economic reversed phase high-performance liquid chromatography (RPHPLC) method has been established for estimation analysis of DRO. A Brownlee ODS C-18 column (250×4.6 mm i.d) chromatographic column equilibrated with mobile phase methanol-0.02 M KH2PO4 (80:20, v/v) (Final pH adjusted to 4 using Orthophosphoric acid) was used. Mobile phase flow rate was maintained at 1 ml/min and effluents were monitored at 289 nm. The sample was injected using a 20 μl fixed loop, and the total run time was 10 min. Experimental conditions such as pH of mobile phase, column saturation time, selection of wavelength, etc. were critically studied and the optimum conditions were selected. In RP-HPLC linear range was found to be 5-15 μg/ml and, mean recovery was found to be 99.99-100.03% and Rt of dronedarone was found to be 4.7 min. Degradation in acid, base, peroxide and thermal was found in range 8-20%. This stability indicating HPLC method is economic, sensitive, and less time consuming than other chromatographic procedures. It is a user-friendly and importance tool for analysis of dronedarone in tablet dosage forms.