Validated RP-HPLC and UV spectrophotometry method for the estimation of atomoxetine hydrochloride in pharmaceutical dosage forms

[摘要] 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.

[学科分类] 药理学