ESTIMATION OF IBUTILIDE FUMARATE IN BULK AND PHARMACEUTICAL FORMULATIONS BY A SIMPLE AND VALIDATED RP-HPLC

Venkat Rao S, Chandrasekhar K, Gopalakrishna A and Ameer SK

A rapid, precise, economical, and accurate HPLC method for estimation of Ibutilide fumarate in bulk and formulations was developed and validated via system suitability method. The chromatographic resolution of Ibutilide was achieved using acetonitrile: 0.1M ammonium dihydrogen phosphate buffer PH~ 6(Phasphoricacid), (25: 75 V/V) as a mobile phase UV detection at 250 nm and Hypersil thermo C18 column at a flow rate of 1.0mL/min. The calibration curve was linear (r2 = 0.9991) over Ibutilide concentration ranging from 20 to 120 μg/mL. The proposed method is also accurate, precise and robust. The method can be used for routine quality control analysis.