HPTLC Determination of Atomoxetine Hydrochloride from its Bulk Drug and Pharmaceutical Preparations

Abstract

A rapid, simple and sensitive high-performance thin layer chromatographic method (HPTLC) has been developed to assay atomoxetine HCl in capsules. The HPTLC analysis used a normal phase (silica gel 60 F 254) as a stationary phase and a mobile phase consisting of mixture of acetonitrile:glacial acetic acid with UV detection at 269 nm. The validation data showed that the assay is sensitive, specific and reproducible for determination of atomoxetine HCl in this dosage form. The calibration curves were linear from 100-1000 μg mL^-1 (R² > 0.997). The accuracy of the method ranged from 99.12 to 99.80 %. Mean inter- and intra-assay relative standard deviations (RSD) were less than 2.0 %. The proposed method provided an accurate and precise analysis of atomoxetine HCl in its pharmaceutical preparations.