DEVELOPMENT AND VALIDATION OF STABILITY INDICATING HPLC METHOD FOR ESTIMATION OF AMIODARONE HYDROCHLORIDE

Santosh V. Gandhi*, Pooja R. Alli and Rupali S. More

ABSTRACT

The aim of the present study was to develop a validated stability indicating reverse phase high performance liquid chromatography (RP-HPLC) method for estimation of Amiodarone hydrochloride. An isocratic, RP-HPLC method was developed using Hi Q SIL C18 (4.6 mm x 250 mm, 5 μm) column, Acetonitrile and 0.5% formic acid (80:20 v/v) as mobile phase at flow rate of 1.0 ml/min. Detection and Quantification was carried at wavelength of 242 nm. The retention time (RT) of drug was 8.329 ± 0.412 min. The method was validated with respect to linearity, precision, accuracy and robustness. The data of linear regression analysis indicated a good linear relationship over the range of 5-30 μg/ml concentrations with a correlation coefficient (R2) of 0.9993. Amiodarone hydrochloride was subjected to different stress testing conditions. The degradation products were well resolved from the drug under the tested conditions.The developed method was found to be simple, sensitive, selective, accurate and precise for analysis of Amiodarone hydrochloride and can be adopted for routine analysis of drug in bulk and pharmaceutical dosage form.

Keywords: High performance liquid chromatography (HPLC), Amiodarone hydrochloride, Stability indicating method, Validation.