Separation and determination of synthetic impurities of sildenafil (vliagra) by reversed-phase high-performance liquid chromatography

被引:24
作者
Nagaraju, V
Sreenath, D
Rao, JT
Rao, RN
机构
[1] AP State Forens Sci Lab, Chem Sect, Hyderabad 500004, Andhra Pradesh, India
[2] Dr Hari Singh Gour Univ, Dept Chem, Sagar 470003, India
[3] Indian Inst Chem Technol, Div Analyt Chem, Hyderabad 500007, Andhra Pradesh, India
关键词
D O I
10.2116/analsci.19.1007
中图分类号
O65 [分析化学];
学科分类号
070302 ; 081704 ;
摘要
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 C-18 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.
引用
收藏
页码:1007 / 1011
页数:5
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