An improved validated ultra high pressure liquid chromatographymethod for separation of tacrolimus impurities and its tautomers

Drug Testing and Analysis

Volumn 2, Issue 3, 2010, Pages 107-112

  Subasranjan, Acharya ^a,b   Srinivasulu, C ^a   Hemant, Raoutray ^b  

^a DR REDDY'S LABORATORIES LTD   (India)

^b RAVENSHAW UNIVERSITY   (India)

Author keywords

Impurities; Method validation; Tacrolimus; Tautomers; UHPLC

Indexed keywords

ACETONITRILE; DEGRADATION; HIGH PRESSURE LIQUID CHROMATOGRAPHY;

ACQUITY UPLC SYSTEMS; CHROMATOGRAPHIC SEPARATIONS; DEGRADATION PRODUCTS; HIGH-PRESSURE LIQUID; METHOD VALIDATIONS; MOBILE PHASIS; TACROLIMUS; TAUTOMER; ULTRA HIGH PRESSURE LIQUID CHROMATOGRAPHY; ULTRA-HIGH;

IMPURITIES;

TACROLIMUS;

ACCURACY; ARTICLE; DRUG DEGRADATION; DRUG IMPURITY; DRUG STRUCTURE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; PRIORITY JOURNAL; SENSITIVITY AND SPECIFICITY;

EID: 77953435081     PISSN: 19427603     EISSN: 19427611     Source Type: Journal    
DOI: 10.1002/dta.112     Document Type: Article

References (26)

1. H. Per, N. Thomas, World Intellectual Property Organization, 2006, WO2005/020994A1.
2. T. Akashi, T. Nefuji, M. Yoshida, J. Hosoda, J. Pharm. Biomed. Anal. 1996, 14, 339.
3. Y. Namiki, A. Fujiwara, N. Kihara, S. Koda, T. Yasuda, Chromatographia 1995, 40, 253.
4. H. Ok, B.H. Arison, R. G. Ball, T. R. Beattie, M.H. Fisher, M. J. Wyvratt, Tetrahedron lett. 1990, 31, 1035.
5. P. E. Wallemacq, R. Reding, Clin. Chem. 1993, 39, 2219.
6. V. B. Borhade, H. A. Nair, D.D. Hegde, C. R. Barhate, Drug Dev. Industrial Pharm. 2009, 35, 440.
7. A. Capron, J. Lerut, C. Verbaandert, J. Mathys, O. Ciccarelli, R. Vanbinst, F. Roggen, C. D. Reyck, J. Lemaire, P. E. Wallemacq, Ther. Drug Monit. 2007, 29, 340.
8. C. E. Staatz, P. J. Taylor, S. E. Tett, Ther. Drug Monit. 2002, 24, 607.
9. K. Abu-Elmagd, J. J. Fung, M. Alessiani, A. Jain, R. Venkataramanan, V. S. Warty, S. Takaya, S. Todo, W. D. Shannon, T. E. Starzl, Transplantation 1991, 52, 71.
10. M. Winkler, U. Jost, B. Ringe, G. Gubernatis, K. Wonigeit, R. Pichlmayr, Transplant Proc. 1991, 23, 3153.
11. L. Backman, M. Nicar, M. Levy, D. Distant, C. Eisenstein, T. Renard, R. Goldstein, B. Husberg, T. Gonwa, G. Klintmalm, Transplant Proc. 1994, 26, 1804.
12. A. J. Beysens, R. M.Wijnen, G. H. Beuman, J. J. Van der Heyden, G. Kootstra, H. As Van, Transplant Proc. 1991, 23, 2745.
13. M. Winkler, B. Ringe, J. Baumann, M. Loss, K. Wonigeit, R. Pichlmayr, Clin. Chem. 1994, 40, 2247.
14. R. Venkataramanan, L. M. Shaw, L. Sarkozi, R. Mullins, J. Pirsch, G. MacFarlane, et al. J. Clin. Pharmacol. 2001, 41, 542.
15. H. Zahir, G. McCaughan, M. Gleeson, R. A. Nand, A. J. McLachlan, Ther. Drug Monit. 2004, 26, 506.
16. V. Warty, R. Venkataramanan, P. Zendehrouh, T. McKaveney, J. Chao, S. Todo, T. Starzl, Transplant Proc. 1991, 23, 954.
17. W. Piekoszewski, W. J. Jusko, J. Pharm. Sci. 1993, 82, 340.
18. P. J. Taylor, R. G. Morrist, Ther. Drug Monit. 2003, 25, 259.
19. A. J. Beysens, G. H. Beuman, J. J. van der Heijden, K. E. J. Hoogtanders, O. M. Steijger, H. Lingeman, Chromatographia 1994, 39, 490.
20. T. Kanji, M. Oh-Hashi, H. Yoshikawa, S. Muranshi, M. Nishiyama, H. Yoshida, T. Hata, H. Tanaka, J. Chromatogr. 1990, 530, 212.
21. A. M. Maria, D. S. Laura, T. P. Maria, I. S. Adriana, Journal of AOAC International. 2006, 89, 1547.
22. ICH. Impurities in new drug substances 3QA, U.S Food and drug Administration, IFPMA, Geneva, 2008.
23. ICH Impurities in new Drug Products 3QB, U.S Food and drug Administration, IFPMA, Geneva, 2006.
24. The United States Pharmacopoeia forum, The United States Pharmacopoeia Convention, Inc. Rockvile, 2008, 35(2), 310 and 312.
25. N. Lucie, S.Dagmar, S. Petr, J. Separation Sci. 2006, 29, 2433.
26. ICH. Validation of analytical procedure: Textmethodology, U.S.Food and drug Administration, IFPMA: Geneva, 2005.