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Stability indicating HPLC method for simultaneous quantification of sildenafil citrate and dapoxetine hydrochloride in pharmaceutical products.

Author(s)
Kai Bin Liew Department of Pharmaceutical Technology, Faculty of Pharmaceutical Sciences, No 1, Jalan Menara Gading,UCSI Height, UCSI University, Cheras, Kuala Lumpur, Malaysia, School of Pharmaceutical Sciences, University Sains Malaysia, Minden, Penang, Malaysia
Kok Khiang Peh School of Pharmaceutical Sciences, University Sains Malaysia,Minden, Penang,Malaysia
Abstract
A stability-indicating HPLC-UV method for the simultaneous determination of sildenafil citrate and dapoxetine hydrochloride in solution and tablet was developed. The mobile phase was comprised of acetonitrile and 0.2M ammonium acetate buffer. The analyte was eluted at 3.392min and 7.255min for sildenafil citrate and dapoxetine HCl respectively using gradient system at a flow rate of 1.5mL/min. The theoretical plates count was>2000, tailing factor <1.30, capacity factor 3.19-7.58 and peak asymmetry factor <1.08.The method was linear from 5-180 and 1-40µg/mL with a correlation coefficient of 0.9999 and 0.9994 for sildenafil citrate and dapoxetine HCl respectively. The drug solution was stable at ambient room temperature (26°C) for 48hours.Both drugs were found susceptible to oxidation and the drug content dropped slightly in acid and alkali condition but stable under UV light and heat. No interference from tablet excipients and degradation products was found.
Publication Details
Page(s) 2515-2522
DOI DOI not available
Published Journal: Pakistan Journal of Pharmaceutical Sciences, Volume: 31, Issue: 6, Year: 2018

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Keywords
stress degradation study
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