Optimisation and validation of a rapid and efficient microemulsion liquid chromatographic (MELC) method for the determination of paracetamol (acetaminophen) content in a suppository formulation

Eamon McEvoy, Sheila Donegan, Joe Power, Kevin Altria

Research output: Contribution to journalArticlepeer-review

70 Citations (Scopus)

Abstract

A rapid and efficient oil-in-water microemulsion liquid chromatographic method has been optimised and validated for the analysis of paracetamol in a suppository formulation. Excellent linearity, accuracy, precision and assay results were obtained. Lengthy sample pre-treatment/extraction procedures were eliminated due to the solubilising power of the microemulsion and rapid analysis times were achieved. The method was optimised to achieve rapid analysis time and relatively high peak efficiencies. A standard microemulsion composition of 33 g SDS, 66 g butan-1-ol, 8 g n-octane in 1 l of 0.05% TFA modified with acetonitrile has been shown to be suitable for the rapid analysis of paracetamol in highly hydrophobic preparations under isocratic conditions. Validated assay results and overall analysis time of the optimised method was compared to British Pharmacopoeia reference methods. Sample preparation and analysis times for the MELC analysis of paracetamol in a suppository were extremely rapid compared to the reference method and similar assay results were achieved. A gradient MELC method using the same microemulsion has been optimised for the resolution of paracetamol and five of its related substances in approximately 7 min.

Original languageEnglish
Pages (from-to)137-143
Number of pages7
JournalJournal of Pharmaceutical and Biomedical Analysis
Volume44
Issue number1
DOIs
Publication statusPublished - 09 May 2007

Keywords

  • Acetaminophen
  • Gradient elution
  • Microemulsion liquid chromatography
  • Paracetamol
  • Related substances
  • Suppository
  • Validation

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