A simple, sensitive, and precise high performance liquid chromatographic method for estimating the contents of Dronedarone Hydrochloride simultaneously has been developed, validated and used in commercial tablet. This method is based (250 mm × 4.6 mm) on Analytical HPLC system having C18 column and mobile phase containing acetonitrile: triethylamine in water pH adjusted to 2.3 with ortho phosphoric acid (70: 30v/v) at flow rate of 1.0 mL/min using UV detection at 290 nm. The linear regression analysis data for the calibration plots showed a good linear relationship over the concentration range of 10.0 60.0µg/mL for Dronedarone Hydrochloride. This stability of the drug was carried out for acidic, alkaline, peroxide, thermal and photolytic conditions. The drug was estimated in presence of its degradation products (if any) without interference. The method was validated for accuracy, precision, robustness and recovery studies as per ICH guidelines. The method can be adopted for routine analysis of drug in its tablet formulation.
Key words: Dronedarone Hydrochloride; HPLC; Validation; Forced Degradation; stability
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