Research Article
K. Vijetha, A. Ramu, S. Vidyad
Abstract
Two simple, precise, and easy methods were successfully developed for the estimation of Atomoxetine hydrochloride in bulk and pharmaceutical dosage forms. The first method was UV-spectrophotometry, which is linear in the concentration range of 20-100μg/ml at maximum absorbance (λmax) 270 nm. The correlation coefficient was found to be 0.999. The accuracy of the method was ranged from 99.5-100.3%. The percent relative standard deviation (%RSD) for precision was found to be less than 2%. The reproducibility of the method was determined based on ruggedness was found to be 0.3-1.4%. The second method was based on reversed-phase high-performance liquid chromatography (RP-HPLC) using acetonitrile: phosphate buffer PH 6.8 (60:40v/v) with 1ml/min flow rate. The detector response was obtained at 270nm. The average retention time for the drug was obtained 4.2±0.003min. The calibration curves were linear from 20-100μg/ml, which was used as in the case of UV-method. The accuracy of the method was determined by percent recovery studies ranged from 99.8 to 101.77%. Mean Intra - and inter- day assay relative standard deviations were 0.9 and 0.4%. Ruggedness and robustness were also calculated not more than 2%. The proposed methods were applied successfully for the analysis of drug in pure and in its dosage forms and validated according to ICH guidelines.