, Volume 40, Issue 5–6, pp 253–258 | Cite as

Determination of the immunosuppressive drug tacrolimus in its dosage forms by high-performance liquid chromatography

  • Y. Namiki
  • A. Fujiwara
  • N. Kihara
  • S. Koda
  • K. Hane
  • T. Yasuda


A high-performance liquid chromatographic (HPLC) method has been developed and validated for the determination of FK506, a new immunosuppressant, in bulk drug samples and dosage forms. Equilibration between FK506 (I) and its tautomeric compounds (II and III) was accomplished “artificially” in water-dehydrated alcohol (1∶1) employed as an extraction solvent. After reaching equilibrium, separation of I, treated as the representetive of equilibrated FK506, from its related substances was achieved by reversed-phase HPLC on a C18 column with water-isopropyl alcohol-tetrahydrofuran (5∶2∶2, v/v) as the mobile phase, and detection at 220 nm. Component I in dosage forms could be recovered satisfactorily and determined with good precision. The calibration graph was linear over the range 2–6 μg for I.

Key Words

Column Liquid Chromatography Immunosuppessive drug FK 506 (Tacrolimus) Tautomeric Phenomenon 


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Copyright information

© Friedr. Vieweg & Sohn Verlagsgesellschaft mbH 1995

Authors and Affiliations

  • Y. Namiki
    • 1
  • A. Fujiwara
    • 1
  • N. Kihara
    • 1
  • S. Koda
    • 1
  • K. Hane
    • 1
  • T. Yasuda
    • 1
  1. 1.Analytical Research LaboratoriesFujisawa Pharmaceutical Co., Ltd.OsakaJapan

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