Analytical Method Development and Validation of Formoterol Fumarate Dihydrate By Chromatographic and Spectrophotometric Techniques

Abstract

Three simple, precise and economical methods have been developed and validated for estimation of Formoterol Fumarate Dihydrate in bulk and in pharmaceutical dosage form. Method A is simple UV spectrophotometric method for estimation of drug in phosphate buffer (pH 3) at 214 nm. Linearity was found in the conc. range of 2-12 µg/ml while the detection and quantitation limits were found to be 0.11 and 0.32 µg/ml respectively. Method B is the first- order derivative spectrometric technique performed at 229 nm, in which linearity was found in the conc. range of 2-12 µg/ml while the detection and quantitation limits were found to be 0.14 and 0.44 µg/ml respectively. Method C is RP-HPLC method in which separation was achieved by gradient elution using an InertsilC18 (150 × 4.6 mm) column, a mobile phase consisting of sodium phosphate buffer (0.01M; pH 3.0): acetonitrile (70:30 v/v), a flow rate of 1.0 ml/min and UV detection at 214 nm. The linearity was obtained in the conc. range of 2-7 µg/ml while the detection and quantitation limits were found to be 0.04 and 0.14 µg/ml respectively. All the three methods were validated successfully across the guidelines in accordance with ICH. Thus, the proposed methods can be used for routine analysis of formoterol fumarate dihydrate as it does not showed any interference of excipients when estimated in pharmaceutical formulations.