A Novel Validated Method for the Determination of Dapoxetine HCl by RP-HPLC in Bulk and Tablet Dosage Forms

Background: The purpose of this study is the development and validation of assay test for Dapoxetine Hydrochloride in the pharmaceutical dosage forms by HPLC. The assay method by HPLC was found to be linear in the concentration range of 25 to 150 μg/mL. The mobile phase was composed of methanol and buffer pH: 7.0 ammonium dihydrogen phosphate (80:20 v/v) at the flow rate of 1 mL/min using UV detection at 232 nm. Results and Conclusion: The analytical results were validated by recovery studies. The percentage recovery method was found to be 99.58-100.75%. The LOD and LOQ were found to 0.008 μg/mL and 0.027 μg/mL. All the parameters of validation were in the acceptance range. This developed method was successfully applied to estimate the amount of Dapoxetine Hydrochloride in the tablets.