Validated uv spectrophotometric method for quantitative analysis of dapoxetine in pharmaceutical dosage form

A simple, precise, accurate, economical and reliable UV spectrophotometric method has been developed for the estimation of Dapoxetine in tablet dosage form. The Dapoxetine shows maximum absorbance at 211 nm in water and obeys Beer’s law in the concentration range of 2-10 μg /mL with good correlation coefficient (r2 = 0.9996). The results of analysis were validated by recovery studies. The percentage recovery method was found to be 99.53-100.41%. The relative standard deviation was found to be < 2.0 % in all cases. The Proposed spectrophotometric method was validated as per the ICH Q2 (R1) guidelines. The method was successfully applied to pharmaceutical formulation because no chromatographic interferences from the tablet excipients were found. The proposed method was found to be accurate and reliable for routine quantification of Dapoxetine in bulk form and pharmaceutical formulations.