Stability-indicating LC assay and determination of system suitability limits with a robustness test of gemifloxacin mesylate in tablets

Current Analytical Chemistry

Volumn 6, Issue 4, 2010, Pages 269-276

  Paim, C S ^a   Fuhr F ^a   Miron, D S ^a   Pereira, R L ^a   Malesuik, M D ^a   Steppe, M ^a   Schapoval, E E S ^a  

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

Author keywords

Experimental design; Gemifloxacin mesylate in tablets; Photodegradation kinetics; System suitability limits; Validation and stability indicating

Indexed keywords

ALKALINITY; CHROMATOGRAPHIC ANALYSIS; DRUG PRODUCTS; LIQUID CHROMATOGRAPHY; RATE CONSTANTS; STATISTICS; SYSTEM STABILITY;

CHROMATOGRAPHIC METHODS; COATED TABLETS; GEMIFLOXACIN MESYLATE IN TABLET; MESYLATES; PEAK PURITIES; PHOTODEGRADATION KINETICS; QUANTITATIVE DETERMINATIONS; STABILITY-INDICATING; SYSTEM SUITABILITY LIMIT; VALIDATION AND STABILITY-INDICATING;

DEGRADATION;

EID: 84859984841     PISSN: 15734110     EISSN: None     Source Type: Journal    
DOI: 10.2174/1573411011006040269     Document Type: Article

References (18)

1. FDA. Food and Drug Administration. Information prescribing. http://www.fda.gov/medwatch/safety/2007/May_PI/Factive_PI.pdf [Acessed May 27, 2007].
2. Cornican, M.G.; Jones, R.N. Antimicrobial activity and spectrum of LB20304, a novel fluoronaphthyridone. Antimicrob. Agents Chemother., 1997, 41, 204-11.
3. Johnson, D.M.; Jones, R.N.; Erwin, M.E. The quality control study group. Anti-streptococcal activity of SB-265805 (LB20304), a novel fluoronaphthyidone, compared with five other compounds, including quality control guidelines. Diagn. Microbiol. Infect. Dis., 1999, 33, 87-91.
4. Grossman, R.; Rotschafer, J.; Tan, J. Antimicrobial treatment of lower respiratory tract infections in the hospital setting. Am. J. Med., 2005, 118, 29S-38S.
5. Doyle, E.; Fowles, S.; Mcdonnell, D.; Mccarthy, R.; White, S. Rapid determination of gemifloxacin in human plasma by highperformance liquid chromatography-tandem mass spectrometry. J. Chromatogr. B, 2000, 746, 191-8.
6. Alen, A.; Bygate, E.; Vousden, M.; Oliver, S.; Johnson, M.; Ward, C.; Cheon, A.; Choo, Y.; Kim, I. Multiple-dose pharmacokinetics and tolerability of gemifloxacin administered orally to healthy volunteers. Antimicrob. Agents Chemother., 2001, 45(2), 540-5.
7. Robledo, V.R.; Smyth, W.F. A study of the analytical behaviour of selected new molecular entities using electrospray ionisation ion trap mass spectrometry, liquid chromatography, gas chromatography and polarography and their determination in serum at therapeutic concentrations. Anal. Chim. Acta, 2008, 623, 221-30.
8. Krishna, M.V.; Sankar, D.G. Utility of α and π-acceptors for the spectrophotometric determination of gemifloxacin mesylate in pharmaceutical formulations. E. J. Chem., 2008, 5(3), 493-8.
9. Krishna, M.V.; Sankar, D.G. Spectrophotometric determination of gemifloxacin mesylate in pharmaceutical formulations through ionpair complex formation. E. J. Chem., 2008, 5(3), 515-20.
10. Paim, C.S.; Gonçalves, H.M.L.; Miron, D.; Steppe, M. Stabilityindication LC determination of entacapone in tablets. Chromatographia, 2007, 65, 595-9.
11. Paim, C.S.; Gonçalves, H.M.L.; Lange, A.; Miron, D. Steppe, M. Validation of UV spectrophotometric method for quantitative determination of entacapone in tablets using experimental design of Plackett-Burman for robustness evaluation and comparison with HPLC. Anal. Lett., 2008, 41(4), 571-81.
12. Heyden, Y.V.; Jimidar, M.; Hund, E.; Niemeijer, R.; Peeters, R.; Smeyers-Verbeke, J.; Massart, D.L.; Hoogmartens, J. Determination of system suitability limits with a robustness test. J. Chromatogr. A, 1999, 845, 145-54.
13. Heyden, Y.V.; Nijhuis, A.; Smeyers-Verbeke, J.; Vandeginste, B.G.M.; Massart, D.L. Guidance for robustness/ruggedness test in method validation. J. Pharm. Biomed. Anal., 2001, 24, 723-53.
14. ICH (2005) Harmonised Tripartite Guideline: Validation of Analytical Procedure: Text and Methodology Q2 (R1). http://www.ich.org/LOB/media/MEDIA417.pdf [Acessed April 27, 2010].
15. ICH (2003) Harmonised Tripartite Guideline: Stability Testing of New Drug Substance and Products: methodology Q1A(R2). http://www.ich.org/LOB/media/MEDIA419.pdf (Acessed April 27, 2010).
16. The United States Pharmacopeia 31th Rockville, MD, 2008.
17. Alsante, K.M.; Ando, A.; Brown, R.; Ensing, R.; Hatajik, T.D.; Kong, W.; Tsuda, Y. The role of degradant profiling in active pharmaceutical ingredients and drug products. Adv. Drug Deliv. Rev., 2007, 59, 29-37.
18. Shabir, G.A. Validation of high-performance liquid chromatography methods for pharmaceutical analysis: understanding the differences and similarities between validation requirements of the US Food and Drug Administration, the US Pharmacopeia and the International Conference on Harmonization. J. Chromatogr. A, 2003, 987, 57-66.