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.
Keywords: Dapoxetine hydrochloride, RP-HPLC, pharmaceutical, validation, analysis, buffer solution, robustness.
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