Validation of a stability-indicating RP-LC method for the determination of tigecycline in lyophilized powder

Journal of Chromatographic Science

Volumn 51, Issue 2, 2013, Pages 192-199

  Da Silva, Lucélia Magalhães ^a   Salgado, Hérida Regina Nunes ^a  

^a SÃO PAULO STATE UNIVERSITY UNESP   (Brazil)

Author keywords

[No Author keywords available]

Indexed keywords

DRUG DERIVATIVE; MINOCYCLINE; TIGECYCLINE;

ARTICLE; CHEMISTRY; DRUG STABILITY; LIMIT OF DETECTION; METHODOLOGY; POWDER; REPRODUCIBILITY; REVERSED PHASE LIQUID CHROMATOGRAPHY; STANDARD; STATISTICAL MODEL;

CHROMATOGRAPHY, REVERSE-PHASE; DRUG STABILITY; LIMIT OF DETECTION; LINEAR MODELS; MINOCYCLINE; POWDERS; REPRODUCIBILITY OF RESULTS;

EID: 84872715689     PISSN: 00219665     EISSN: None     Source Type: Journal    
DOI: 10.1093/chromsci/bms126     Document Type: Article

References (24)

1. Peterson, L.R; A review of tigecycline-The first glycylcycline; International Journal of Antimicrobial Agent, (2008); 32: S215-S222.
2. Bhattacharya, M., Parakh, A., Narang, M.; Tigecycline; Journal Postgraduate Medicine, (2009); 55: 65-68.
3. Chopra, I.; Glycylcyclines: Third-generation tetracycline antibiotics; Current Opinion in Pharmacology, (2001); 1: 464-469. (Pubitemid 33593834)
4. Hoffmann, M., Demaio, W., Jordan, R.A., Talaat, R., Harper, D., Speth, J., et al.; Metabolism, excretion, and pharmacokinetics of [14C] tigecycline, a first-in-class glycylcycline antibiotic, after intravenous infusion to healthy male subjects; Drug Metabolism and Disposition, (2007); 35: 1543-1553. (Pubitemid 47296047)
5. Bauer, G., Berens, C., Projan, S.J., Hillen, W.; Comparison of tetracycline and tigecycline binding to ribosomes mapped by dimethylsulphate and drug-directed Fe2 cleavage of 16S rRNA; Journal of Antimicrobial Chemotherapy, (2004); 53: 592-599. (Pubitemid 38499772)
6. Zhanel, G.G., Homenuik, K., Nichol, K., Noreddin, A., Vercaigne, L., Embil, J., et al.; The glycylcyclines: A comparative review with the tetracyclines; Drugs, (2004); 64: 63-88. (Pubitemid 38125629)
7. Pankey, G.A.; Tigecycline; Journal of Antimicrobial Chemotherapy, (2005); 56: 470-480. (Pubitemid 41264122)
8. Garrison, M.W., Neumiller, J.J., Setter, S.M.; Tigecycline: An investigational glycylcycline antimicrobial with activity against resistant Gram-positive organisms; Clinical Therapeutics, (2005); 27: 12-22. (Pubitemid 40342574)
9. Doan, T., Fung, H.B., Mehta, D., Riska, P.F.; Tigecycline: A glycylcycline antimicrobial agent; Clinical Therapeutics, (2006); 28: 1079-1106. (Pubitemid 44376809)
10. Silva, L.M., Salgado, H.R.N.; Tigecycline: A review of properties, applications, and analytical methods; Therapeutic Drug Monitoring, (2010); 32: 282-288.
11. Li, C., Sutherland, C.A., Nightingale, C.H., Nicolau, D.P.; Quantitation of tigecycline, a novel glycylcycline, by liquid chromatography; Journal of Chromatography B, (2004); 811: 225-229. (Pubitemid 39446769)
12. Bradford, P.A., Petersen, P.J., Young, M., Jones, C.H., Tischler, M., O'Connell, J.; Tigecycline MIC testing by broth dilution requires use of fresh medium or addition of the biocatalytic oxygenreducing reagent oxyrase to standardize the test method; Antimicrobial Agents and Chemotherapy, (2005); 49: 3903-3909. (Pubitemid 41233048)
13. Muralidharan, G., Micalizzi, M., Speth, J., Raible, D., Troy, S.; Pharmacokinetics of tigecycline after single and multiple doses in healthy subjects; Antimicrobial Agents and Chemotherapy, (2005); 49: 220-229. (Pubitemid 40065796)
14. Conte, J.E., Jr., Golden, J.A., Kelly, M.G., Zurlinden, E.; Steady-state serum and intrapulmonary pharmacokinetics and pharmacodynamics of tigecycline; International Journal of Antimicrobial Agents, (2005); 25: 523-529. (Pubitemid 40732607)
15. Ji, A.J., Saunders, J.P., Amorusi, P., Wadgaonkar, N.D., O'Leary, K., Leal, M., et al.; A sensitive human bone assay for quantitation of tigecycline using LC/MS/MS; Journal of Pharmaceutical and Biomedical Analysis, (2008); 48: 866-875.
16. Ji, A.J., Saunders, J.P., Wadgaonkar, N.D., Petersen, P.J., O'Leary, K., McWilliams, W.E., et al.; A novel antibiotic bone assay by liquid chromatography/tandem mass spectrometry for quantitation of tigecycline in rat bone; Journal of Pharmaceutical and Biomedical Analysis, (2007); 44: 970-979. (Pubitemid 47103248)
17. International Conference on Harmonization (ICH); Technical Requirements for the Registration of Pharmaceuticals for Human Use. Stability Testing of New Drugs Substance and Products Q1A(R2), (2003
18. Ivana, I., Ljiljana, Z., Mira, Z.; A stability indicating assay method for cefuroxime axetil and its application to analysis of tablets exposed to accelerated stability test conditions; Journal of Chromatography A, (2006); 1119: 209-215. (Pubitemid 43831897)
19. International Conference on Harmonization (ICH); Technical Requirements for the Registration of Pharmaceuticals for Human Use. Validation of analytical procedures: Text and methodology Q2(R1), (2005
20. Alsante, K.M., Ando, A., Brown, R., Ensing, J., Hatajik, T.D., Kong, W., et al.; The role of degradant profiling in active pharmaceutical ingredients and drug products; Advanced Drug Delivery Reviews, (2007); 59: 29-37. (Pubitemid 46204933)
21. Youden, W.J., Steiner, E.H.; Statistical manual of the Association of Official Analytical Chemists. AOAC International, Gaithersburg, MD, (1998), pp. 33, 70, 82.
22. César, I.C., Pianetti, G.A.; Robustness evaluation of the chromatographic method for the quantitation of lumefantrine using Youden's test; Brazilian Journal of Pharmaceutical Sciences, (2009); 45: 235-240.
23. Bedregal, P., Torres, B., Ubillús, M., Mendonza, P., Montoya, E.; Robustness in NAA evaluated by the Youden and Steiner test; Journal of Radioanalytical and Nuclear Chemistry, (2008); 278: 801-806.
24. Oka, H., Ito, Y., Matsumoto, H.; Chromatographic analysis of tetracycline antibiotics in foods; Journal of Chromatography A, (2000); 882: 109-133. (Pubitemid 30323703).