Gemifloxacin mesylate (GFM) stability evaluation applying a validated bioassay method and in vitro cytotoxic study

Talanta

Volumn 83, Issue 5, 2011, Pages 1774-1779

  Paim, Clésio S ^a   Führ, Fernanda ^a   Barth, Aline B ^a   Gonçalves, Carlos E I ^a   Nardi, Nance ^a   Steppe, Martin ^a   Schapoval, Elfrides E S ^a  

^a FEDERAL UNIVERSITY OF RIO GRANDE DO SUL   (Brazil)

Author keywords

Fluoroquinolones; Gemifloxacin; In vitro cytotoxicity assay; Microbiological assay; Staphylococcus epidermidis

Indexed keywords

CYTOTOXICITY; DRUG PRODUCTS; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HYDROLYSIS; QUALITY CONTROL;

FLUOROQUINOLONES; GEMIFLOXACIN; IN-VITRO; MICROBIOLOGICAL ASSAYS; STAPHYLOCOCCUS EPIDERMIDIS;

BIOASSAY;

EID: 78751572827     PISSN: 00399140     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.talanta.2010.11.069     Document Type: Article

References (25)

1. FDA, Food and Drug Administration, Information prescribing, http://www.fda.gov/medwatch/safety/2007/May-PI/Factive-PI.pdf.
2. D.M. Johnson, R.N. Jones, and M.E. Erwin Diagn. Microbiol. Infect. Dis. 33 1999 87
3. R. Grossman, J. Rotschafer, and J. Tan Am. J. Med. 118 2005 29S
4. L.S. Ev, and E.E.S. Schapoval J. Pharm. Biomed. Anal. 27 2002 91
5. H.R.N. Marona, and E.E.S. Schapoval Informacion Tecnologica 9 1998 251
6. H.R.N. Salgado, C.C.G.O. Lopes, and M.B.B. Lucchesi J. Pharm. Biom. Anal. 40 2006 443
7. F.L.B. Guerra, C.S. Paim, M. Steppe, and E.E.S. Schapoval J. AOAC Int. 88 2005 1086
8. M.J. Souza, C.F. Bittencourt, and P.S. Souza Int. J. Pharm. 271 2004 287
9. A. Alen, E. Bygate, M. Vousden, S. Oliver, M. Johnson, C. Ward, A. Cheon, Y. Choo, and I. Kim Antimicrob. Agents Chemother. 45 2001 540
10. E. Doyle, S. Fowles, D. McDonnell, R. McCarthy, and S. White J. Chromatogr. B 746 2000 191
11. V.R. Robledo, and W.F. Smyth Anal. Chim. Acta 623 2008 221
12. M.V. Krishna, and D.G. Sankar E-J. Chem. 5 2008 493
13. M.V. Krishna, and D.G. Sankar E-J. Chem. 5 2008 515
14. M.J. Souza, R.R. Kulmann, L.M. Silva, D.R. Nogueira, E.S. Zimmermann, and C.A. Schmidt J. AOAC Int. 89 2006 1367
15. I.C.H. Harmonised Tripartite Guideline: Impurities in New Drug Products - Q3B(R2) 2006 Commission of the European Communities Geneva pp. 1-11
16. Farmacopéia Brasileira, 4th ed., Atheneu, São Paulo, 1988. Parte I, v.5.2.17-v.5.2.17-11.
17. The United States Pharmacopoeia, 32nd ed. (USP 32), United States Pharmacopoeia Convention, Rockville, MD, 2009.
18. European Pharmacopoeia, 5th ed. European Directorate for the Quality of Medicines, Strasbourg Cedex, France, 2005, pp. 1695-1697.
19. W. Hewitt Microbiological Assay for Pharmaceutical Analysis: a Rational Approach 2003 Interpharm Boca Raton
20. International Conference on Harmonization of Technical Requirements for the Registration of Pharmaceutical for Human Use: Validation of Analytical Procedures, Text and Methodology - Q2(R1), 2005.
21. N.A. Hodjes M.E. Aulton, Pharmaceutics: The Science of Dosage Form Design 2001 Churchill Livingstone London 623 643
22. K.M. Alsante, A. Ando, R. Brown, R. Ensing, T.D. Hatajik, W. Kong, and Y. Tsuda Adv. Drug Deliv. Rev. 59 2007 29
23. A. Foroumadi, M. Oboudiat, S. Emami, A. Karimollah, L. Saghaee, M.H. Moshafid, and A. Shafieea Bioorg. Med. Chem. 14 2006 3421
24. A. Pardakhty, A. Foroumadi, M. Hashemi, S. Rajabalian, and M. Heidari Toxicol. In Vitro 21 2007 1031
25. R.M. Baird, and N.A. Hodges Handbook of Microbiological Quality Control 2000 Taylor & Francis London