Separation and Determination of Synthetic Impurities of Sildenafil (Viagra) by Reversed-Phase High-Performance Liquid Chromatography

A 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...

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Veröffentlicht in:	Analytical Sciences 2003, Vol.19(7), pp.1007-1011
Hauptverfasser:	NAGARAJU, Velupula, SREENATH, Dasari, RAO, Jammula TIRUMALA, RAO, Ramisetti NAGESWARA
Format:	Artikel
Sprache:	eng
Schlagworte:	Analysis Biological and medical sciences Chemical reactions Chromatography, High Pressure Liquid - methods Drug Contamination Flow rates General pharmacology Liquid chromatography Medical sciences Molecular Structure Pharmacology. Drug treatments Piperazines - chemical synthesis Piperazines - chemistry Purines Quality assurance Sensitivity and Specificity Sildenafil Citrate Sulfones Ultraviolet radiation
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Beschreibung
Zusammenfassung:	A 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.
ISSN:	0910-6340 1348-2246
DOI:	10.2116/analsci.19.1007