Abstract:
The present study was undertaken to develop a spectrophotometric method for the determination of Dapoxetine in pharmaceutical dosage forms. This paper reports a simple, rapid, accurate and precise UV-Spectrophotometric method for the assay of Dapoxetine in bulk and marketed tablet dosage form has been developed. The validation of the designed method was also carried out in terms of linearity, precision, accuracy, specificity, limit of detection, limit of quantification and by performing recovery study. Beer’s law was obeyed in the concentration range of 5- 35 µg/ml with a good correlation coefficient (r=0.999). Method is validated as per ICH guidelines and this study is statistically significant as all the statistical parameters are within the acceptance range (% RSD < 2.0 and SD < 2.0) for both accuracy and precision.

Keywords: Dapoxetine, UV Spectrophotometer, Method Validation, Dosage Form.