UHPLC for quality evaluation of genuine and illegal medicines containing sildenafil citrate and tadalafil.

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  • Additional Information
    • Source:
      Publisher: Oxford University Press Country of Publication: United States NLM ID: 0173225 Publication Model: Print Cited Medium: Internet ISSN: 1945-239X (Electronic) Linking ISSN: 00219665 NLM ISO Abbreviation: J Chromatogr Sci Subsets: MEDLINE
    • Publication Information:
      Publication: <2012- > : Oxford : Oxford University Press
      Original Publication: Niles Il : Preston Technical Abstracts
    • Subject Terms:
      Illicit Drugs*/analysis ; Illicit Drugs*/chemistry ; Sildenafil Citrate*/analysis ; Sildenafil Citrate*/chemistry ; Sildenafil Citrate*/standards ; Tadalafil*/analysis ; Tadalafil*/chemistry ; Tadalafil*/standards; Chromatography, High Pressure Liquid/*methods; Counterfeit Drugs ; Limit of Detection ; Linear Models ; Reproducibility of Results ; Tandem Mass Spectrometry
    • Abstract:
      One of the highest incidences of illegal drug products is related to phosphodiesterase-5 inhibitors, used in treatment of erectile dysfunction, including those containing sildenafil citrate and tadalafil. In this context, comprehensive evaluation of the quality of genuine and illegal medicines was performed. A simple and rapid ultra-high performance liquid chromatography (UHPLC-UV) method to quantify sildenafil and tadalafil in the presence of six degradation products was developed and validated. Sildenafil and tadalafil were submitted to forced degradation. The separation was carried out on a Kinetex C18 (50 × 2.1 mm; 1.7 μm) column with mobile phase composed of acetonitrile and aqueous triethylamine solution. The calibration curves were linear in the range of 14-126 μg mL-1 for sildenafil citrate and 4-36 μg mL-1 for tadalafil and the method proved to be selective, precise, accurate and robust. Sildenafil degraded in oxidative media, whereas tadalafil degraded in acidic, alkaline and oxidative environment. The chemical structures and the mechanisms for the formation of the main degradation products were proposed by UHPLC coupled to tandem mass spectrometry. The UHPLC-UV method was applied in the pharmaceutical analysis of genuine and seized medicines. Some of them did not meet quality standards, mainly due to contents below specifications and the large variation on contents between units within a batch.
      (© The Author(s) 2020. Published by Oxford University Press. All rights reserved. For Permissions, please email: [email protected].)
    • Accession Number:
      0 (Counterfeit Drugs)
      0 (Illicit Drugs)
      742SXX0ICT (Tadalafil)
      BW9B0ZE037 (Sildenafil Citrate)
    • Publication Date:
      Date Created: 20201027 Date Completed: 20210503 Latest Revision: 20210503
    • Publication Date:
      20240829
    • Accession Number:
      10.1093/chromsci/bmaa073
    • Accession Number:
      33107906