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2017 | 20 | 2 |

Tytuł artykułu

Determination of tigecycline in turkey plasma by LC-MS/MS: validation and application in a pharmacokinetic study

Treść / Zawartość

Warianty tytułu

Języki publikacji

EN

Abstrakty

EN
Tigecycline (TIG), a novel glycylcycline antibiotic, plays an important role in the management of complicated skin and intra-abdominal infections. The available data lack any description of a method for determination of TIG in avian plasma. In our study, a selective, accurate and reversed-phase high performance liquid chromatography-tandem mass spectrometry method was developed for the determination of TIG in turkey plasma. Sample preparation was based on protein precipitation and liquid-liquid extraction using 1,2-dichloroethane. Chromatographic separation of TIG and minocycline (internal standard, IS) was achieved on an Atlantis T3 column (150 mm x 3.0 mm, 3.0 μm) using gradient elution. The selected reaction monitoring transitions were performed at 293.60 m/z → 257.10 m/z for TIG and 458.00 m/z → 441.20 m/z for IS. The developed method was validated in terms of specificity, selectivity, linearity, lowest limit of quantification, limit of detection, precision, accuracy, matrix effect, carry-over effect, extraction recovery and stability. All parameters of the method submitted to validation met the acceptance criteria. The assay was linear over the concentration range of 0.01-100 μg/ml. This validated method was successfully applied to a TIG pharmacokinetic study in turkey after intravenous and oral administration at a dose of 10 mg/kg at various time-points.

Słowa kluczowe

Wydawca

-

Rocznik

Tom

20

Numer

2

Opis fizyczny

p.241-249,fig.,ref.

Twórcy

  • Department of Pharmacology and Toxicology, Faculty of Veterinary Medicine, University of Warmia and Mazury, Oczapowskiego 13, 10-718 Olsztyn, Poland
  • Department of Pharmacology and Toxicology, Faculty of Veterinary Medicine, University of Warmia and Mazury, Oczapowskiego 13, 10-718 Olsztyn, Poland

Bibliografia

  • Bauer G, Berens C, Projan SJ, Hillen W (2004) Comparison of tetracycline and tigecycline binding to ribosomes mapped by dimethylsulphate and drug-directed Fe2+ cleavage of 16S rRNA. J Antimicrob Chemother 53: 592-599.
  • Bhattacharya I, Gotfried MH, Ji AJ, Saunders JP, Gourley I, Diehl A, Korth-Bradley JM (2014) Reassessment of tigecycline bone concentrations in volunteers undergoing elective orthopedic procedures. J Clin Pharmacol 54: 70-74.
  • Conte JE Jr, Golden JA, Kelly MG, Zurlinden E (2005) Steady-state serum and intrapulmonary pharmacokinetics and pharmacodynamics of tigecycline. Int J Antimicrob Agents 25: 523-529.
  • EMA (2011) Guideline on Bioanalytical Method Validation. http://www.ema.europa.eu/docs/en–GB/document–library/Scientific–guideline/2011/08/WC500109686.pdf.
  • FDA (2013) Guidance for Industry Bioanalytical Method Validation. https://www.fda.gov/downloads/Drugs/Guidances/ucm368107.pdf.
  • Hoffmann M, DeMaio W, Jordan RA, Talaat R, Harper D, Speth J, Scatina J (2007) Metabolism, excretion, and pharmacokinetics of [14C] tigecycline, a first-in-class glycylcycline antibiotic, after intravenous infusion to healthy male subjects. Drug Metab Dispos 35: 1543-1553.
  • Ji AJ, Saunders JP, Amorusi P, Wadgaonkar ND, O’Leary K, Leal M, Dukart G, Marshall B, Fluhler EN (2008) A sensitive human bone assay for quantitation of tigecycline using LC/MS/MS. J Pharm Biomed Anal 48: 866-875.
  • Ji AJ, Saunders JP, Wadgaonkar ND, Petersen PJ, O’Leary K, McWilliams WE, Amorusi P, Leal M, Fluhler EN (2007) A novel antibiotic bone assay by liquid chromatography/tandem mass spectrometry for quantitation of tigecycline in rat bone. J Pharm Biomed Anal 44: 970-979.
  • Munyeza CF, Shobo A, Baijnath S, Bratkowska D, Naiker S, Bester LA, Singh SD, Maguire GM, Kruger HG, Naicker T, Govender T (2016) Development and validation of a liquid chromatography-tandem mass spectrometry (LC-MS/MS) method for the quantification of tigecycline in rat brain tissues. Biomed Chromatogr 30: 837-845.
  • Muralidharan G, Micalizzi M, Speth J, Raible D, Troy S (2005) Pharmacokinetics of tigecycline after single and multiple doses in healthy subjects. Antimicrob Agents Chemother 49: 220-229.
  • Ozcimen M, Sakarya Y, Ozcimen S, Goktas S, Sakarya R, Alpfidan I, Erdogan E (2014) Pharmacokinetics of intravenously administered tigecycline in eye compartments: an experimental study. Graefes Arch Clin Exp Ophthalmol. 252: 1993-1997.
  • Pai MP (2014) Serum and urine pharmacokinetics of tigecycline in obese class III and normal weight adults. J Antimicrob Chemother 69: 190-199.
  • Rodvold KA, Gotfried MH, Cwik M, Korth-Bradley JM, Dukart G, Ellis-Grosse EJ (2006) Serum, tissue and body fluid concentrations of tigecycline after a single 100 mg dose. J Antimicrob Chemother 58: 1221-1229.
  • Sun HK, Ong CT, Umer A, Harper D, Troy S, Nightingale CH, Nicolau DP (2005) Pharmacokinetic profile of tigecycline in serum and skin blister fluid of healthy subjects after multiple intravenous administrations. Antimicrob Agents Chemother 49: 1629-1632.
  • Xie J, Wang T, Wang X, Cheng X, Dong H, Wang Y, Zheng X, Zhou L, Xing J, Dong Y (2014) Quantitative analysis and pharmacokinetics study of tigecycline in human serum using a validated sensitive liquid chromatography with tandem mass spectrometry method. J Sep Sci 37: 1396-1403.
  • Ziółkowski H, Grabowski T, Jasiecka A, Zuśka-Prot M, Barski D, Jaroszewski JJ (2016) Pharmacokinetics of oxytetracycline in broiler chickens following different routes of administration. Vet J 208: 96-98.

Typ dokumentu

Bibliografia

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