Development and validation of a simple and sensitive LC-MS/MS method for quantification of ampicillin and sulbactam in human plasma and its application to a clinical pharmacokinetic study

Nalbant, Demet; Reeder, Joshua A.; Li, Peizhi; O'Sullivan, Cormac T; Rogers, William Kirke; An, Guohua

doi:10.1016/j.jpba.2021.113899

Cited by 13 publications

(4 citation statements)

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“…Therefore, we conclude that blood sampling for PRF should be performed after a short distribution period post infusion, to ensure the highest possible concentration in the PRF product. This is in line with the result that the SAM concentrations in PRF we measured approximately 17 min after SAM infusion are slightly higher than plasma SAM concentrations reported in the literature [ 8 , 32 , 35 ].…”

Section: Discussionsupporting

confidence: 93%

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Investigation of three common centrifugation protocols for platelet-rich fibrin (PRF) as a bio-carrier for ampicillin/sulbactam: a prospective trial

Straub,

Utz,

Stapf

et al. 2023

Clin Oral Invest

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Objectives Different platelet-rich fibrin (PRF) protocols exist and are known to differ in resulting mechanical and bioactive properties. Centrifugation parameters may also influence drug release, in particular antibiotics, when using PRF as a bio-carrier. We thus evaluated three common protocols regarding effects on the bio-carrier properties. Materials and methods In a prospective trial comprising 33 patients, we compared different protocols for PRF as a bio-carrier for ampicillin/sulbactam (SAM). Blood samples were taken shortly after a single dose of ampicillin/sulbactam (2 g/1 g) was administered to patients intravenously. PRF was obtained by centrifugation and three protocols were used: protocol A (1300 rpm, 8 min, RCF-max = 208 g), B (2300 rpm, 12 min, RCF-max = 652 g), and C (1500 rpm, 14 min, RCF-max = 276 g). The antibacterial activity of PRF was investigated against five oral species in vitro, based on agar diffusion methodology. Results The study demonstrates that a single dose of SAM is sufficient to reach high concentrations in PRF in all protocols (150 µg/ml), which is comparable to the plasma SAM concentration. Antibacterial activity was inferred from the diameter of inhibition zones seen in agar diffusion tests using PRF discs. Protocol B resulted in the largest inhibition zones. One-way ANOVA revealed statistically improved results for protocol B for some bacteria. Conclusions The study provides valuable data on PRF antibiotic enrichment, notably SAM. A single dose of SAM is sufficient to reach clinically relevant concentrations in PRF. Clinical relevance These findings potentially extend the application of PRF, for example in patients with osteonecrosis of the jaw or in oral surgery (e.g., stick bone).

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Section: Discussionsupporting

confidence: 93%

“…A high correlation between the time period between infusion and blood sampling with the plasma antibiotic concentration has already been described [ 30 , 31 , 35 ]. Wildfeuer et al measured for example a SAM plasma concentration of 97/37.6 µg/ml 30 min after infusion.…”

Section: Discussionmentioning

confidence: 99%

Investigation of three common centrifugation protocols for platelet-rich fibrin (PRF) as a bio-carrier for ampicillin/sulbactam: a prospective trial

Straub,

Utz,

Stapf

et al. 2023

Clin Oral Invest

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“…16 Several LC-MS/MS-based methods for the determination of various b-lactam ATB in human plasma have been reported recently. 14,[17][18][19][20][21][22][23][24][25][26][27] These methods involve a relatively simple sample preparation step based on protein precipitation using acetonitrile or methanol, centrifugation, and dilution of the obtained supernatant. Only 1 previous study has used the liquid-liquid extraction method for sample preparation.…”

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confidence: 99%

An Ultra-High-Performance Liquid Chromatography–Tandem Mass Spectrometry Method for Simultaneous Determination of 4 β-Lactam Antibiotics, Tazobactam, and Linezolid in Human Plasma Samples

Piešťanský

Cizmarova

Prof

et al. 2022

Therapeutic Drug Monitoring

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Background: Optimization of antimicrobial therapy is a challenge in critically ill patients who develop extreme interindividual and intraindividual pharmacokinetic variability. Therapeutic drug monitoring is a valuable tool for maximizing the effect of a drug and minimizing its adverse and unwanted effects. The aim of the current work was to develop and validate an ultra-high-performance liquid chromatography-tandem mass spectrometry (UHPLC-MS/MS) method to determine multiple antibiotics in clinical plasma samples from critically ill patients; low sample volume and rapid processing of samples were considered the main criteria.Methods: A separation method based on an online combination of UHPLC-MS/MS was developed for the simultaneous determination of 4 b-lactam antibiotics (cefepime, meropenem, cefotaxime, and piperacillin), tazobactam, and linezolid in human plasma samples. The volume of plasma sample used for analysis was 20 mL. The developed method was validated according to Food and Drug Administration guidelines. Results:The chromatographic run time was 8 minutes. Calibration curves were linear for concentration ranges of 0.1-100 mcg/mL (r 2 . 0.99) for tazobactam, meropenem, cefotaxime, linezolid, and piperacillin and 1-100 mcg/mL (r 2 . 0.99) for cefepime. The intraday and interday accuracy of the method ranged from 92.4% to 110.7% and 93.6% to 113.3%, respectively. The intraday and interday pre-cision values were #17.3% and #17.4%, respectively. No interfering and carryover analytes were observed. Conclusions:The developed UHPLC-MS/MS method is an appropriate and practical tool for therapeutic drug monitoring of the selected antibiotics. Owing to its rapidity, requirement of low sample volume, and high selectivity, sensitivity, and reliability, it can be effectively implemented in routine clinical laboratory tests for critically ill patients.

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“…In the secondary mass spectrometry results, the main fragments are m / z 140, m / z 64, and m / z 90. It has been reported in the literature that for sulbactam in negative ion mode, the quantitative ion is m / z 140, and the qualitative ion is m / z 64 [ 46 , 47 , 48 ]. It could be seen that the retention time and the characteristic ion fragment for the metabolite are consistent with those of the sulbactam standard.…”

Section: Discussionmentioning

confidence: 99%

A Comprehensive Study to Identify Major Metabolites of an Amoxicillin–Sulbactam Hybrid Molecule in Rats and Its Metabolic Pathway Using UPLC-Q-TOF-MS/MS

et al. 2022

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Amoxicillin and sulbactam are widely used compound drugs in animal food. The amoxicillin–sulbactam hybrid molecule can achieve better curative effects through the combination of the two drugs. However, its pharmacokinetic behavior needs to be explored. In this study, a randomized crossover experiment was performed to investigate the metabolism of the novel amoxicillin–sulbactam hybrid molecule in rats after gastric administration. Ultrahigh performance liquid chromatography–quadrupole time-of-flight tandem mass spectrometry (UPLC-Q-TOF-MS/MS) was used to isolate and to identify the metabolites in rats. Amoxicillin, amoxicilloic acid, amoxicillin diketopiperazine, and sulbactam were eventually detected in the plasma, liver, urine, and kidneys; no hybrid molecules and their metabolites were detected in feces. The in vivo metabolism results showed that the hybrid molecule was absorbed into the body in the intestine, producing amoxicillin and sulbactam, then amoxicillin was partially metabolized to amoxicilloic acid and amoxicillin diketopiperazine, which are eventually excreted in the urine by the kidneys. In this study, four major metabolites of the amoxicillin–sulbactam hybrid molecule were identified and their metabolic pathways were speculated, which provided scientific data for understanding the metabolism of the hybrid molecule and for its clinical rational use.

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Development and validation of a simple and sensitive LC-MS/MS method for quantification of ampicillin and sulbactam in human plasma and its application to a clinical pharmacokinetic study

Cited by 13 publications

References 13 publications

Investigation of three common centrifugation protocols for platelet-rich fibrin (PRF) as a bio-carrier for ampicillin/sulbactam: a prospective trial

Investigation of three common centrifugation protocols for platelet-rich fibrin (PRF) as a bio-carrier for ampicillin/sulbactam: a prospective trial

An Ultra-High-Performance Liquid Chromatography–Tandem Mass Spectrometry Method for Simultaneous Determination of 4 β-Lactam Antibiotics, Tazobactam, and Linezolid in Human Plasma Samples

A Comprehensive Study to Identify Major Metabolites of an Amoxicillin–Sulbactam Hybrid Molecule in Rats and Its Metabolic Pathway Using UPLC-Q-TOF-MS/MS

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