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

E-ISSN： 1875-676x|14|6|622-626

ISSN： 1573-4129

Source： Current Pharmaceutical Analysis, Vol.14, Iss.6, 2018-11, pp. : 622-626

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Abstract

Background: The purpose of this study is the development and validation of assay test forDapoxetine Hydrochloride in the pharmaceutical dosage forms by HPLC. The assay method by HPLCwas found to be linear in the concentration range of 25 to 150 #181;g/mL. The mobile phase was composedof methanol and buffer pH: 7.0 ammonium dihydrogen phosphate (80:20 v/v) at the flow rate of 1mL/min using UV detection at 232 nm.

Results and Conclusion: The analytical results were validated by recovery studies. The percentagerecovery method was found to be 99.58-100.75%. The LOD and LOQ were found to 0.008 #181;g/mL and0.027 #181;g/mL. All the parameters of validation were in the acceptance range. This developed methodwas successfully applied to estimate the amount of Dapoxetine Hydrochloride in the tablets.