Available online www.jocpr.com Journal of Chemical and Pharmaceutical Research, 2014, 6(7):1613-1618 Research Article ISSN : 0975-7384 CODEN(USA) : JCPRC5 1613 Development and validation of a HPLC analytical assay method for dapoxetine tablets: A medicine for premature ejaculation Arun M. Kashid 1 , Santosh A. Waghmare 1 , Satish D. Thombare 1 , Mahesh S. Agalawe 1 and Shashikant C. Dhawale 2 1 Department of Pharmaceutical Chemistry, Sinhgad Institute of Pharmacy, Narhe, Pune, Maharashtra, India 2 Department of Pharmacology, School of Pharmacy, SRTM University, Nanded, Maharashtra, India _____________________________________________________________________________________________ ABSTRACT A simple, specific, accurate, and precise r everse p hase High Perf ormance Liquid Chromatographic (RP- HPLC) method was developed and validated f or the estimation of Dapoxetine HCl in bulk and pharmaceutical dosage f orms. A Symmet ry C18, 3.5 μ m column having 250 mm x 4.6 mm in isocratic mode, with mobile phase containing HPLC grade Acetonit rile, 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 o f Dapoxetine HCl at retention time of 5.020 ± 0.0078 min. The Correlation coefficient was 0.999. The method was validated f or linearity, sensitivity, precision, accuracy , robustness. The limit o f detection and limit of quantitation f or estimation o f Dapoxetine HCl was found to be 0.142 and 0.471, respectively. Recovery of Dapoxetine was f ound to be in the range of 98.93-99.91 %. Proposed method was successfully applied f or the quantitative determination of Dapoxetine H C l in bulk and pharmaceutical dosage f orms. RP-HPLC method for Dapoxetine was Developed and validated according to ICH guidelines. Key words: Dapoxetine H C l , Premature Ejaculation, HPLC etc. _____________________________________________________________________________________________ INTRODUCTION Recently it has been suggested that Premature Ejaculation (PE) might be associated with the perturbation in seretonergic 5- hydroxytryptamine neurotransmission. It has been proposed that PE may be caused by decreased central serotonergic signaling, hyposensitivity of 5-HT 2 C receptor, or hypersensitivity of the 5-HT 1A receptor, all of which have been shown to decrease ejaculatory latency time in men. PE is common problem, which may be associated with considerably anxiety frustration and negative impact on affected men and their sexual partners. Dapoxetine H C l an oral serotonin transporter inhibitor, was effective for the treatment of men with premature ejaculation. Dapoxetine H C l is designated chemically as (S)-N, N dimethyl-3-(naphthalen-1-yloxy)-1- phenylpropan-1-amine, is mainly used as erectile dysfunction as selective short acting potent serotonin reuptake inhibitor (SSRI). Dapoxetine H C l mechanism of action is thought to be inhibition of neuronal reuptake of serotonin and subsequent potentiation of serotonin activity and increase the ejaculation time. Literature survey reveals less information about the determination of dapoxetine H C l by the HPLC method. The developed method was validated as per ICH guidelines Q2 R1. [1, 2, 3]