Quantitative analysis and pharmacokinetics study of tigecycline in human serum using a validated sensitive liquid chromatography with tandem mass spectrometry method

Xie, Jiao; Wang, Taotao; Wang, Xue; Cheng, Xiaoliang; Dong, Haiyan; Wang, Yan; Zheng, Xiaowei; Zhou, Liang; Xing, Jianfeng; Dong, Yalin

doi:10.1002/jssc.201400152

Cited by 17 publications

(26 citation statements)

References 29 publications

(26 reference statements)

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“…The blood samples were collected into Vacutainer tubes (Becton Dickinson, Franklin Lakes, NJ, USA) and were immediately centrifuged at 3,500 rpm for 5 min; the resultant supernatants were stored frozen at Ϫ80°C until analysis. The serum tigecycline concentrations of blood samples were measured by an established liquid chromatography-tandem mass spectrometry method (15). The assay was linear over the concentration range of 0.005 to 2 mg/liter.…”

Section: Methodsmentioning

confidence: 99%

Population Pharmacokinetics of Tigecycline in Critically Ill Patients with Severe Infections

Xie

Roberts

Alobaid

et al. 2017

Antimicrob Agents Chemother

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We sought to describe the population pharmacokinetics of tigecycline in critically ill patients and to determine optimized dosing regimens of tigecycline for different bacterial infections. This prospective study included 10 critically ill patients given a standard dose of tigecycline. Blood samples were collected during one dosing interval and were analyzed using validated chromatography. Population pharmacokinetics and Monte Carlo dosing simulations were undertaken using Pmetrics. Three target exposures, expressed as ratios of the 24-h area under the curve to MICs (AUC 0 -24 /MIC), were evaluated (Ն17.9 for skin infections, Ն6.96 for intraabdominal infections, Ն4.5 for hospital-acquired pneumonia). The median age, total body weight, and body mass index (BMI) were 67 years, 69.1 kg, and 24.7 kg/m 2 , respectively. A two-compartment linear model best described the time course of tigecycline concentrations. The parameter estimates (expressed as means Ϯ standard deviations [SD]) from the final model were as follows: clearance (CL), 7.50 Ϯ 1.11 liters/h; volume in the central compartment, 72.50 Ϯ 21.18 liters; rate constant for tigecycline distribution from the central to the peripheral compartment, 0.31 Ϯ 0.16 h Ϫ1 ; and rate constant for tigecycline distribution from the peripheral to the central compartment, 0.29 Ϯ 0.30 h Ϫ1 . A larger BMI was associated with increased CL of tigecycline. Licensed doses were found to be sufficient for Enterobacter cloacae, Escherichia coli, Klebsiella pneumoniae, and methicillin-resistant Staphylococcus aureus for an AUC 0 -24 /MIC target of 4.5 or 6.96. For a therapeutic target of 17.9, an increased tigecycline dose is required, especially for patients with higher BMI. The dosing requirements of tigecycline differ with the indication, with pathogen susceptibility, and potentially with patient BMI.

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Section: Methodsmentioning

confidence: 99%

Population Pharmacokinetics of Tigecycline in Critically Ill Patients with Severe Infections

Xie

Roberts

Alobaid

et al. 2017

Antimicrob Agents Chemother

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“…Although TIG recovery was lower than those achieved by Munyeza et al (2016) and Xie et al (2014), which were 82.4% and 94.3%, respectively, the method presented in this article is characterized by similarly high sensitivity compared to the methods used in the aforementioned studies. The matrix effect for TIG for turkey plasma was 2.36%, indicating that endogenous components from plasma did not affect the repeatability.…”

Section: Extraction Recovery and Matrix Effectmentioning

confidence: 78%

“…In the early phase of the experiment, individual ions of the TIG analytical standard were monitored at 586.3 m/z → 513.3 m/z ion transition, according to detection parameters described in available literature (Hoffmann et al 2007, Ji et al 2007, Ji et al 2008, Bhattacharya et al 2014, Xie et al 2014. However, the sensitivity of the method was very low (≥400 ng/ml), which would not ensure reliable results with respect to pharmacokinetics of TIG administered orally, where the absorption of the drug was much lower than after IV administration.…”

Section: Discussionmentioning

confidence: 99%

“…However, in contrast to LLE extraction, SPE method is time-and labour-consuming, because it includes numerous steps needed to perform the entire extraction process. The literature describes the procedure of sample preparation for LC-MS/MS determination of TIG, which involved the addition of acetonitrile (Conte et al 2005, Muralidharan et al 2005, Ozcimen et al 2014, an internal standard dissolved in acetonitrile (Rodvold et al 2006, Bhattacharya et al 2014 or trifluoroacetic acid (Hoffmann et al 2007, Xie et al 2014) to a sample. However, our test extraction of TIG from turkey plasma with all the above methods was ineffective, which manifested itself by additional, unidentified peaks appearing in chromatograms.…”

Section: Discussionmentioning

confidence: 99%

“…There are only a few reports on determination of TIG; the validated LC-MS/MS assay was developed for determination of TIG in human plasma (Conte et al 2005, Rodvold et al 2006, Hoffmann et al 2007, Pai 2014, Xie et al 2014, bone (Ji et al 2007, Ji et al 2008, Bhattacharya et al 2014) and skin blister (Sun et al 2005). Most of the methods for determination of TIG in a biological matrix mentioned above lack sufficient information about the settings of a detector, therefore any attempt to their adaptation to animal experiments may cause difficulties and often require optimization followed by repeated validation.…”

Section: Introductionmentioning

confidence: 99%

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

Jasiecka-Mikołajczyk

Jaroszewski

2017

Polish Journal of Veterinary Sciences

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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.

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Development and validation of a liquid chromatography‐tandem mass spectrometry (LC‐MS/MS) method for the quantification of tigecycline in rat brain tissues

Munyeza

Shobo

Baijnath

et al. 2015

Biomedical Chromatography

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Tigecycline (TIG), a derivative of minocycline, is the first in the novel class of glycylcyclines and is currently indicated for the treatment of complicated skin structure and intra-abdominal infections. A selective, accurate and reversed-phase high-performance liquid chromatography-tandem mass spectrometry (HPLC-MS/MS) method was developed for the determination of TIG in rat brain tissues. Sample preparation was based on protein precipitation and solid phase extraction using Supel-Select HLB (30 mg/1 mL) cartridges. The samples were separated on a YMC Triart C18 column (150 mm x 3.0 mm. 3.0 µm) using gradient elution. Positive electrospray ionization (ESI+) was used for the detection mechanism with the multiple reaction monitoring (MRM) mode. The method was validated over the concentration range of 150-1200 ng/mL for rat brain tissue. The precision and accuracy for all brain analyses were within the acceptable limit. The mean extraction recovery in rat brain was 83.6%. This validated method was successfully applied to a pharmacokinetic study in female Sprague Dawley rats, which were given a dose of 25 mg/kg TIG intraperitoneally at various time-points. Copyright © 2015 John Wiley & Sons, Ltd.

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Quantitative analysis and pharmacokinetics study of tigecycline in human serum using a validated sensitive liquid chromatography with tandem mass spectrometry method

Cited by 17 publications

References 29 publications

Population Pharmacokinetics of Tigecycline in Critically Ill Patients with Severe Infections

Population Pharmacokinetics of Tigecycline in Critically Ill Patients with Severe Infections

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

Development and validation of a liquid chromatography‐tandem mass spectrometry (LC‐MS/MS) method for the quantification of tigecycline in rat brain tissues

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