Determination of minocycline in human plasma by high-performance liquid chromatography coupled to tandem mass spectrometry: application to bioequivalence study

J Chromatogr B Biomed Sci Appl. 2001 May 5;755(1-2):1-7. doi: 10.1016/s0378-4347(00)00472-2.

Abstract

Minocycline was determined in human plasma by HPLC-MS-MS using clarithromycin as an internal standard. The method is fast (single liquid extraction and run time of <3 min) and sensitive (5 ng/ml) and it was employed in a bioequivalence study of two 100 mg tablet formulations in 24 healthy volunteers. The 90% confidence interval of the individual ratio geometric mean for both AUC(0-96 h) and Cmax were 99.2-111.1% and 95.6-117.5%, respectively. Thus, Minoderm was considered bioequivalent to Minomax according to both the rate and extent of absorption. No food interaction was observed with either formulation.

Publication types

  • Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Oral
  • Anti-Bacterial Agents / blood*
  • Anti-Bacterial Agents / pharmacokinetics*
  • Area Under Curve
  • Chromatography, High Pressure Liquid / methods
  • Clarithromycin / standards
  • Food-Drug Interactions
  • Humans
  • Mass Spectrometry
  • Minocycline / administration & dosage
  • Minocycline / blood*
  • Minocycline / pharmacokinetics*
  • Reference Standards
  • Tablets
  • Therapeutic Equivalency

Substances

  • Anti-Bacterial Agents
  • Tablets
  • Minocycline
  • Clarithromycin