Separation and Determination of Synthetic Impurities of Sildenafil (Viagra) by Reversed-Phase High-Performance Liquid Chromatography
2003; Springer Nature; Volume: 19; Issue: 7 Linguagem: Inglês
10.2116/analsci.19.1007
ISSN1348-2246
AutoresVelupula Nagaraju, Dasari Sreenath, Jammula Tirumala Rao, R. Nageswara Rao,
Tópico(s)Pharmaceutical Quality and Counterfeiting
ResumoA simple and rapid high-performance liquid chromatographic method for the separation and determination of process-related impurities of sildenafil was developed. The separation was achieved on a reversed-phase C18 column using acetonitrile-0.05 M potassium dihydrogen orthophosphate (70:30 v/v) as a mobile solvent at a flow rate of 1.0 ml/min and UV detection at 230 nm. The method was used not only for quality assurance, but also for monitoring the chemical reactions during the synthesis of sildenafil. It was found to be specific, precise and reliable for the determination of all process-related impurities of sildenafil in bulk drugs and formulations.
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