Abstract
VALIDATION OF HYDROTROPIC SOLUBILIZATION BASED RP-HPLC METHOD FOR ESTIMATION OF AMIODARONE

*Ritesh Kumar Gupta, Vivek Thakur, Deepak Basedia and Balkrishna Dubey

ABSTRACT

A new RP-HPLC method was developed for the estimation of amiodarone in tablets using hydrotropic solubilisation technique and it was validated as per ICH guidelines. The chromatogram for was found to be satisfactory on symmetry C-18 (4.6×150mm, 5μ Thermosil column) using 5% urea solution at a flow rate of 1.0 ml/min. The retention time of amiodarone was found to be 3.715 min. The system suitability parameters proved that the proposed method is suitable for estimation of amiodarone. Tailing factor for the peak was found to be 1.18 and the theoretical plates for separation were found to be 9071. The method was found to be linear in the range of 10-50μg/ml. The precision of the method was good and the recovery of drugs is well within the acceptance limits of 80-120%. The LOD and LOQ were found to be 0.024μg/ml and 0.08 μg/ml respectively. The proposed RP HPLC method was found suitable for the estimation of amiodarone in formulations and is simple, selective, reproducible and accurate with good precision and can be successfully applied to routine analytical purpose.

Keywords: Amiodarone, hydrotropy, HPLC, estimation, validation, ICH guidelines.


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