Abstract

METHOD DEVELOPMENT AND VALIDATION FOR THE ESTIMATION OF ATOMOXETINE HYDROCHLORIDE IN BULK AND CAPSULE DOSAGE FORM BY RP-HPLC

G. Swathi*, A. Srividya, A. Ajitha, Dr. V. Uma Maheswar Rao

ABSTRACT

A simple, rapid, precise, specific and accurate RP-HPLC method has been developed for the determination of Atomoxetine, a drug used in attention deficit hyperactivity disorder (ADHD) in bulk and pharmaceutical dosage forms. Chromatography was performed on an Hypersil BDS C8 column (250 x 4.6 mm), packed with 5μm particles using mobile-phase as a combination of Methanol: Phosphate Buffer pH 3 and (80:20v/v) with (0.1%TEA) at a flow rate of 1.0 mL/min. UV detection was performed at 271 nm and the Rt of 4.33 min to elute the Atomoxetine was achieved successfully. Results of analysis were validated statistically according to ICH guidelines with respect to accuracy, precision, linearity, specificity and robustness. Linear calibration plots were obtained between 100-200 μg/mL and the %RSD of the method was found to be less than 2%. The mean %Recovery of the drug from a sample solution containing 150μg/ml was 100.06 indicating high accuracy of the proposed method. The suggested method can be successfully employed for the routine estimation of Atomoxetine, in capsule dosage form and the excipients present in the formulations do not interfere with the assay procedure.

Keywords: Atomoxetine hydrochloride, RP-HPLC, Validation.