Stability studies of rifampicin in plasma and urine of tuberculosis patients according to the European Medicines Agency Guidelines

Bioanalysis. 2019 Apr;11(8):713-726. doi: 10.4155/bio-2018-0174. Epub 2019 Apr 17.

Abstract

Aim: The macrolide antibiotic rifampicin is prescribed against several infections, like tuberculosis disease. This drug decays to rifampicin quinone. Results/methodology: The biological fluids were diluted in a micellar solution and directly injected. Using a C18 column and a mobile phase of 0.15 M SDS-6% 1-pentanol phosphate-buffered at pH 7, running at 1 ml/min, the analytes were resolved in less than 15 min. The detection was by absorbance at 337 nm. Method was validated by the guidelines of the European Medicines Agency. Decomposition of rifampicin to rifampicin quinone was also studied. Discussion/conclusion: Procedure is rapid, easy-to-handle, economic, eco-friendly and with a high sample throughput. It was successfully used to monitor rifampicin in the plasma and urine of tubercular patients.

Keywords: plasma and urine samples; rifampicin; stability studies; tuberculosis; validation.

MeSH terms

  • Antibiotics, Antitubercular / pharmacology
  • Antibiotics, Antitubercular / therapeutic use*
  • Europe
  • Guidelines as Topic
  • Humans
  • Rifampin / pharmacology
  • Rifampin / therapeutic use*
  • Tuberculosis / blood*
  • Tuberculosis / pathology
  • Tuberculosis / urine*

Substances

  • Antibiotics, Antitubercular
  • Rifampin