Stability Studies of Rifampicin in Plasma and Urine of Tuberculosis Patients According to the European Medicines Agency Guidelines

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 0.15M SDS-6% 1-pentanol phosphate-buffered at pH 7, running at 1ml/min, the analytes were resolved in less than 15min. The detection was by absorbance at 337nm. 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

Acknowledgments

The authors are thankful to Madhya Pradesh Council & Technology (MPCOST), Bhopal, Madhya Pradesh (India) and University Grants Commission (UGC), New Delhi (India) for providing Junior Research Fellowship. The authors also want to thank the support of project AICO-2017-063 of Conselleria d’Educació de la Generalitat Valenciana and project UJI-B2018-20 from the Universitat Jaume I. Also, J Albiol-Chiva thank the AICO Project for its predoctoral contract.

Financial & competing interests disclosure

The authors have no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

No writing assistance was utilized in the production of this manuscript.