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

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Abstract

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.

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Authors and Affiliations

  1. Chemistry Section, A. P. State Forensic Science Laboratory, Red Hills, Hyderabad, 500 004, India

    Velupula Nagaraju

  2. Department of Chemistry, Dr. Hari Singh Gour University, Sagar, 470 003, India

    Dasari Sreenath & Jammula Tirumala Rao

  3. Analytical Chemistry Division, Indian Institute of Chemical Technology, Tarnaka, Hyderabad, 500 007, India

    Ramisetti Nageswara Rao

Authors
  1. Velupula Nagaraju
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  2. Dasari Sreenath
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  3. Jammula Tirumala Rao
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  4. Ramisetti Nageswara Rao
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Nagaraju, V., Sreenath, D., Tirumala Rao, J. et al. Separation and Determination of Synthetic Impurities of Sildenafil (Viagra) by Reversed-Phase High-Performance Liquid Chromatography. ANAL. SCI. 19, 1007–1011 (2003). https://doi.org/10.2116/analsci.19.1007

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  • DOI: https://doi.org/10.2116/analsci.19.1007

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