Summary
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.
This is a preview of subscription content, log in via an institution to check access.
Similar content being viewed by others
References
H. Tanaka, A. Kuroda, H. Marusawa, H. Hatanaka, T. Kino, T. Goto, M. Hashimoto, T. Taga, J. Am. Chem. Soc.,109, 5031 (1987).
T. E. Starzl, J. Fung, R. Venkataramman, S. Todo, A. J. Demetris, A. Jain, Lancet,i, 1000 (1989).
S. L. Schreiber, G. R. Crabtree, Immunology Today,13, 136 (1992).
M. K. Rosen, R. F. Standaert, A. Galat, M. Nakatsuka, S. L. Schreiber, Science,248, 863 (1990).
G. D. Van Duyne, R. F. Standaert, P. A. Karplus, S. L. Schreiber, J. Clardy, Science,252, 839 (1991).
D. F. Mielke, P. Schmieder, P. Karuso, H. Kessler, Helv. Chim. Acta,74, 1027 (1991).
H. Joshua, Rainin Dynamax, Review, June, 3 (1991).
D. E. Henderson, J. A. Mello, J. Chromatogr.,499, 79 (1990).
K. Tamura, M. Kobayashi, K. Hashimoto, K. Kojima, K. Nagase, K. Iwasaki, T. Kaizu, H. Tanaka, M. Niwa, Transplant. Proc.,19, suppl 6, 23 (1987).
K. Takada, M. Oh-hashi, H. Yoshikawa, S. Muranishi, M. Nishiyama, H. Yoshida, T. Hata, H. Tanaka, J. Chromatogr.,530, 212 (1990).
M. C. Friob, A. Hassoun, D. Latinne, G. Lhoest, J. B. Otte, P. E. Wallenmacq, Transplant. Proc.,23, 2750 (1991).
U. Christians, F. Braun, N. Kosian, M. Schmidt, H. M. Schiebel, L. Ernst, C. Kruse, M. Winkler, I. Holze, A. Linck, K.-Fr. Sewing, Transplant Proc.,23, 2741 (1991).
U. Christians, C. Kruse, R. Kownatzki, H. M. Schiebel, R. Schwinzer, M. Sattler, R. Schottmann, A. Linck, V. M. F. Almeida, F. Braun, K.-Fr. Sewing, Transplant. Proc.,23, 940 (1991).
M. Kobayashi, K. Tamura, N. Katayama, K. Nakamura, K. Nagase, K. Hane, T. Tutumi, M. Niwa, H. Tanaka, K. Iwasaki, M. Kohsaka, Transplant. Proc.,23, 2725 (1991).
D. Taormina, H. Y. Abdallah, R. Venkataramanan, L. Logue, G. J. Burckart, R. J. Ptachcinski, S. Todo, J. J. Fung, T. E. Starzl, AJHP,49, 119 (1992).
K. Hane, M. Fujioka, Y. Namiki, T. Kitagawa, N. Kihara, K. Shimatani, T. Yasuda, Iyakuhin Kenkyu23, 33 (1992).
Y. Namiki, N. Kihara, S. Koda, K. Hane, T. Yasuda, J. Antibiot.,46, 1149 (1993).
Y. Namiki, A. Fujiwara, N. Kihara, S. Koda, K. Hane, T. Yasuda, “Drug Development and Industrial Pharmacy”, in press.
H. Hatanaka, T. Kino, S. Miyata, N. Imamura, A. Kuroda, T. Goto, H. Tanaka, M. Okumura, J. Antibiot.,41, 1592 (1988).
H. Ok, B. H. Arison, R. G. Ball, T. R. Beattie, M. H. Fisher, M. J. Wyvratt, Tetrahedron Lett.,31, 6477, (1990).
K. Uchida, the Japanese FK506 Study Group, Transplant. Proc.,23, 3085 (1991).
Author information
Authors and Affiliations
Rights and permissions
About this article
Cite this article
Namiki, Y., Fujiwara, A., Kihara, N. et al. Determination of the immunosuppressive drug tacrolimus in its dosage forms by high-performance liquid chromatography. Chromatographia 40, 253–258 (1995). https://doi.org/10.1007/BF02290354
Received:
Revised:
Accepted:
Issue Date:
DOI: https://doi.org/10.1007/BF02290354