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Development and validation of RP-HPLC method for the determination of Atomoxetine Hydrochloride in Pharmaceutical Dosage Forms

A simple, reliable, specific, accurate and precise reverse phase high performance liquid chromatographic method was developed and validated for the determination of Atomoxetine HCl in pharmaceutical dosage form. Chromatographic separation was carried on RP-C8 column (Phenomenex, size: 250×4.60 mm, particle size 5μm) with a mobile phase composed of acetonitrile and 10 mM disodium hydrogen phosphate buffer with 0.1% TEA (pH 3.0, adjusted with OPA) (55:45, v/v) in isocratic mode at a flow rate of 1mL/min. The detection was monitored at 271nm. The retention time for Atomoxetine was found to be 3.08 min. The method was found to be linear in the range of 50-150μg/mL. The proposed method can be used for the estimation of Atomoxetine HCl in bulk and pharmaceutical dosage forms for routine quality control analysis

Author(s): Gurmeet Chhabra, Chandraprakash Jain, Saurabh K Banerjee

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