Journal of Chemical and Pharmaceutical Research (ISSN : 0975-7384)

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Original Articles: 2014 Vol: 6 Issue: 7

Development and validation of a HPLC analytical assay method for dapoxetine tablets: A medicine for premature ejaculation

Abstract

A simple, specific, accurate, and precise r everse p hase High Performance Liquid Chromatographic (RPHPLC) method was developed and validated for the estimation of Dapoxetine HCl in bulk and pharmaceutical dosage forms. A Symmetry C18, 3.5 μm column having 250 mm x 4.6 mm in isocratic mode, with mobile phase containing HPLC grade Acetonitrile, Ammonium format (60 : 40 v/v, pH 3.5) was used. The flow rate was 1 ml/min and effluent was monitored at 292 nm. Chromatogram showed a main peak of Dapoxetine HCl at retention time of 5.020 ± 0.0078 min. The Correlation coefficient was 0.999. The method was validated for linearity, sensitivity, precision, accuracy, robustness. The limit of detection and limit of quantitation for estimation of Dapoxetine HCl was found to be 0 .1 42 and 0.471, respectively. Recovery of Dapoxetine was found to be in the range of 98.93-99.91 %. Proposed method was successfully applied for the quantitative determination of Dapoxetine HCl in bulk and pharmaceutical dosage forms. RP-HPLC method for Dapoxetine was Developed and validated according to ICH guidelines.