Abstract

A cost-effective and innovative reverse phase high performance liquid chromatography (RP-HPLC) technique has been devised to accurately and precisely measure the quantity of Atomoxetine Hydrochloride in both large quantities and solid dosage forms. The separation process was conducted using an Xterra RP 18 column with dimensions of 250 mm × 4.6 mm and a particle size of 5 µ. The experiment used the isocratic technique, with a mobile phase consisting of a 70:30 (v/v) mixture of water and methanol. The mobile phase was injected into the column using a pump, with a flow rate of 1.0 mL min-1. The eluent from the column was detected using a UV detector set to operate at a wavelength of 280 nm. The experiment had a duration of 5 minutes, during which the column was consistently kept at the ambient temperature. The determined retention time for Atomoxetine Hydrochloride was 3.08 minutes. The standard curves exhibited a linear relationship throughout the concentration range of 02-10 µg/ml, with a high coefficient of determination (R2 = 0.9997). The study resulted in a variety of percentage recoveries, ranging from 99% to 101%. Moreover, the Relative Standard Deviation (RSD) was computed to be 0.290%. The measured percentage composition of a commercially available formulation of Atomoxetine Hydrochloride was determined to be 100.18%. The approach was verified in accordance with the requirements set out by the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH). The suggested RP-HPLC technique has been validated via research, showcasing its characteristics of simplicity, specificity, speed, reliability, and uniformity. Therefore, the approach suggested in this study may be used for the regular analysis of Atomoxetine Hydrochloride in both its concentrated and solid states, specifically with the aim of assuring quality control.

Description