Volume :
4
Issue :
3
Abstract :
A simple rapid sensitive, precise method has been developed for the estimation of amiodarone in pharmaceutical dosage form (Injection) using Hypersil BDS C18 column (150mm×4.6mm) 5µm, used for the separation. The mobile phase consisting of Acetonitrile: Triethylamine buffer (75:25) of pH 6.5 adjusted with ortho-phosphoric acid. The conditions optimized were: flow rate (2 ml/minute), wavelength (240 nm) and run time was 10min. This method is validated for System suitability, Specificity, Accuracy, Linearity, Range and Robustness. The precision was calculated as repeatability, inter and intraday variation (%RSD) for the drug and met all specifications as per ICH guidelines. The proposed method is good for obtaining reliable results and found to be suitable for the routine analysis in amiodarone in pharmaceutical dosage form.