A SIMPLE ASSAY METHOD DEVELOPMENT AND VALIDATION OF ATOMOXETINE HYDROCHLORIDE IN TABLETS BY UV SPECTROPHOTOMETRY

Objective: To develop a simple and a cheap UV spectrophotometric method for the quantitative estimation of Atomoxetine Hydrochloride in capsules and validate as per ICH guidelines. Method: The optimized method uses 0.05N HCl as a solvent for the estimation of assay of Atomoxetine Hydrochloride in tablets at a wavelength of 225 nm. Results: The developed method resulted in Atomoxetine Hydrochloride exhibiting linearity in the range 5- 40μg/ml. System precision, intra day and inter day precisions were exemplified by relative standard deviation of 1.39%, 1.547% and 1.063%. Percentage Mean recovery by absolute method was found to be in the range of 90‐110%, during accuracy studies. The limit of detection (LOD) and limit of quantitiation (LOQ) for Atomoxetine hydrochloride were found to be 154ng/ml and 467ng/ml respectively. Conclusion: A simple and a cheap UV spectrophotometric method was developed and validated for the quantitative estimation of Atomoxetine Hydrochloride in tablets as per ICH guidelines and hence it can be used for the routine analysis in various pharmaceutical industries. Keywords: UV, Atomoxetine Hydrochloride, method development, validation.