Development and validation of a rapid resolution liquid chromatographic (RRLC) method for the determination of Atomoxetine HCl in its pharmaceutical dosage form

Abstract

The present work described the development of a rapid resolution liquid chromatographic (RRLC) method for atomoxetine in its pharmaceutical dosage form Strattera ®. The analysis was achieved on Agilent Eclipse XDB C18 column (50 mm x 4.6 mm i.d, 1.8 mm particle size) using mixture of aqueous 0.04 M Glacial acetic acid and 0.03M triethylamine (TEA), pH 4.6 - Acetonitril (42 : 58, v/v) as mobile phase at flow rate of 0.27 ml/min and UV detection at 220 nm. The developed method was linear over the concentration range of 4-40 mg /ml (r = 0.99969) with a limit of detection and quantitation 0.44 mg /ml and 1.32 mg /ml for atomoxetine. The developed RRLC method was validated with respect to specificity, linearity, accuracy, and precision, limit of detection and limit of quantitation. The statistical analysis proved that the developed method for quantification of atomoxetine as bulk drug and from pharmaceutical preparation is reproducible and selective. The proposed RRLC method can be used fo the quality control of formulated products containing atomoxetine. Rapid resolution liquid chromatography RRLC has become an increasingly useful approach to achieve higher throughput, improve sensitivity and reduce costs. The agilent 1200 rapid resolution LC system enables faster analysis (theoretically up to 20x) than with conventional high performance liquid chromatography (HPLC) while maintaining equivalent resolution. This is achieved by using sub-2 micron column particle chemistry.