Method development and validation of amiodarone in bulk and pharmaceutical dosage form by RP-HPLC


  • S. S. Patil
  • Y. H. Shaikh
  • C. V. Panchal
  • S. J. Wakode
  • B. N. Poul


Amiodarone, System Suitability, Precision, Accuracy, ICH Guidelines


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.