Simultaneous quantification of cefpodoxime proxetil and clavulanic acid in human plasma by LC–MS using solid phase extraction with application to pharmacokinetic studies

Dubala, Anil; Nagarajan, Janaki Sankarachari Krishnan; Vimal, Chandran Sathish; George, Renjith

doi:10.1016/j.jchromb.2013.01.018

Cited by 15 publications

(7 citation statements)

References 17 publications

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“…In parallel with this increased interest in optimizing dosing of β-lactam antibiotics through TDM and/or pharmacokinetic studies, there has been a growing effort to develop analytical methods that are suitable for this (Bailón-Pérez, García-Campaña, del Olmo-Iruela, Gámiz-Gracia, & Cruces-Blanco, 2009;Bruck, Roberts, Roberts, & Robertson, 2014; Cohen-wolkowiez, White, Bridges, Benjamin, & Kashuba, 2011;D'Cunha et al, 2018;Dubala, Sankarachari, Nagarajan, Vimal, & George, 2013;El-Najjar, Hösl, Holzmann, Jantsch, & Gessner, 2018;Fagerquist, Lightfield, & Lehotay, 2005;Ferrari et al, 2019;Huang, Gao, & Miao, 2012;Khuroo, Monif, Verma, & Gurule, 2008;Lara, del Olmo-Iruela, Cruces-Blanco, Quesada-Molina, & García-Campaña, 2012;Larmené-Beld, Vries-Koenjer, ter Horst, & Hospes, 2014;Lefeuvre et al, 2017;Mameli et al, 2019;Martenslobenhoffer & Bode-böger, 2017;Neugebauer, Wichmann, Bremer-Streck, Hagel, & Kiehntopf, 2019;Ohmori, Suzuki, Niwa, Ushikoshi, & Shirai, 2011;Parker et al, 2019;Partani, Gurule, Khuroo, Monif, & Bhardwaj, 2010;Rigo-Bonnin et al, 2017;Souza, Felton, Crass, Hanaya, & Pai, 2020;Szultka, Krzeminski, Szeliga, Jackowski, & Buszewski, 2013). However, very few analytical methods comply with the high number of stringent requirements that are indispensable for efficient TDM.…”

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confidence: 99%

“…Amoxicillin and clavulanic acid are relatively polar and small compounds that additionally suffer from a lot of interference originating from the plasma matrix. As a result, previously published methods for quantification of amoxicillin and/or clavulanic acid had time-consuming low-throughput sample-preparation steps and used laborious procedures such as solid-phase extraction (Dubala, Sankarachari, Nagarajan, Vimal, & George, 2013;Khuroo, Monif, Verma, & Gurule, 2008;Szultka, Krzeminski, Szeliga, Jackowski, & Buszewski, 2013) or back extraction with dichloromethane combined with multiple centrifugation steps (Carlier et al, 2012). Moreover, in contrast to other β-lactam antibiotics, amoxicillin and clavulanic acid require negative ionization for sensitive quantification.…”

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confidence: 99%

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A sensitive and high‐throughput quantitative liquid chromatography high‐resolution mass spectrometry method for therapeutic drug monitoring of 10 β‐lactam antibiotics, linezolid and two β‐lactamase inhibitors in human plasma

Vooren

Verstraete

2021

Biomedical Chromatography

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An ultra-high pressure liquid chromatography high-resolution mass spectrometric (UHPLC-HRMS) method was developed for the simultaneous and sensitive quantification of 10 β-lactam antibiotics (cefepime, meropenem, amoxicillin, cefazolin, benzylpenicillin, ceftazidime, piperacillin, flucloxacillin, cefuroxime and aztreonam), linezolid and β-lactamase inhibitors tazobactam and clavulanic acid in human plasma. Validation according to the EMA guidelines showed excellent withinand between-run accuracy and precision (i.e. between 1.1 and 8.5%) and high sensitivity (i.e. lower limit of quantification between 0.25 and 1 mg/L). The UHPLC-HRMS method enables a short turnaround time and high sensitivity and needs only a small amount of plasma, allowing appropriate routine therapeutic drug monitoring.The short turnaround time is obtained by speeding up the protocol on multiple levels, i.e. fast and workload-efficient sample preparation (i.e. protein precipitation and dilution), short (4 min) instrument run time, simultaneous measurement of all relevant β-lactam antibiotics used in the intensive care unit and the use of the same instrument, column and mobile phases as for the other routine methods in our laboratory. K E Y W O R D Sβ-lactam antibiotics, HRMS, therapeutic drug monitoring | INTRODUCTIONSevere infection and associated septic shock persist as significant healthcare concerns as they are the most common cause of mortality in critically ill patients worldwide (Vincent et al., 2009). Since adequate and early administration of antibiotics remains the mainstay of therapy for the treatment of severe infections, there is a high level of consumption of antibiotics in intensive care units (ICU) (Dellinger et al., 2013). A single-day point prevalence study showed that 71% of the ICU patients received antimicrobial therapy (Vincent et al., 2009). However, in specific patient populations like critically ill patients, cystic fibrosis patients, elderly patients, neonates, etc., the pharmacokinetics of these antibiotics may be profoundly disturbed owing to pathophysiological changes in distribution and elimination (Roberts et al., 2014;Taccone et al., 2010;Theuretzbacher, 2012). Consequently, an empirical fixed dose approach, in which every patient is treated according to the same dosing scheme, appears to be inadequate and can lead to excessive drug exposure with an increased risk of toxicity or inadequate drug exposure with clinical failure and/or antimicrobial resistance (Roberts & Lipman, 2006). Optimizing antibiotic dosing may be a key intervention, not only to improve clinical outcome and minimize toxicity, but also to prolong the clinical lifespan of the currently available antibiotics by limiting the emergence of

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confidence: 99%

mentioning

confidence: 99%

A sensitive and high‐throughput quantitative liquid chromatography high‐resolution mass spectrometry method for therapeutic drug monitoring of 10 β‐lactam antibiotics, linezolid and two β‐lactamase inhibitors in human plasma

Vooren

Verstraete

2021

Biomedical Chromatography

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“…There has only been a single report regarding analysis of cefpodoxime in biological fluid (human plasma) by LC‐MS (Dubala et al ., ). Cefpodoxime in human plasma was determined by SPE with chloramphenicol as an IS on HPLC‐APCI‐MS.…”

Section: Lc‐ms(/ms) Determination Of Third‐generation Cephalosporinsmentioning

confidence: 97%

“…A Princeton SPHER C 18 column was used for chromatographic separation of extracted plasma samples. A standard linear curve ranging from 0.04 to 4.4 µg/mL was obtained, and the quantification of cefpodoxime was performed using selected ion monitoring (SIM) mode in negative mode at m / z 408, owing to its high selectivity (Dubala et al ., ). LC‐MS/MS technology has not been applied for quantification of cefpodoxime.…”

Section: Lc‐ms(/ms) Determination Of Third‐generation Cephalosporinsmentioning

confidence: 97%

“…With regard to pharmacokinetic applications of cefpodoxime, Dubala et al . () reported that the mean C max and T max of cefpodoxime were 2.1 µg/mL and 3.1 h, respectively, with tablets containing 200 mg of cefpodoxime and 125 mg of clavulanic acid in human subjects by validated LC‐MS methods (Dubala et al ., ). RP UV‐HPLC assay in male dogs indicated mean cefpodoxime C max values of 13.7 and 27.1 µg/mL with T max of 3.5 and 2 h for doses of 5 and 10 mg/kg, respectively (Kumar et al ., ).…”

Section: Pharmacokinetic Applications Of Third‐generation Cephalosporinsmentioning

confidence: 99%

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Recent bioanalytical methods for quantification of third‐generation cephalosporins using HPLC and LC‐MS(/MS) and their applications in pharmacokinetic studies

Jin

Maeng

2014

Biomedical Chromatography

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Third-generation cephalosporins are semi-synthetic antibiotics with enhanced activity against Gram-negative organisms. The cephalosporins in biological samples are mostly determined using high-performance liquid chromatography (HPLC) and HPLC-mass spectrometry (LC-MS) or tandem mass spectrometry (LC-MS/MS). In recent years, numerous bioanalytical methods have been developed to improve the sensitivity and specificity of cephalosporin quantification using the powerful LC-MS/MS systems that are common in research laboratories. This review article presents recently developed bioanalytical methods by HPLC or LC-MS(/MS) for 12 third-generation cephalosporins, including five oral third-generation cephalosporins, and further discusses their application in pharmacokinetic studies of animals and humans.

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Quantification of 16 cephalosporins in the aquatic environment by liquid chromatography‐tandem mass spectrometry

Kaddah

Al-Dokhmaisy

Mansour

et al. 2022

J of Separation Science

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Antimicrobial agents are essential to protect human and animal health. During the coronavirus disease 2019 pandemic, antimicrobials such as cephalosporins were widely used as prophylactics and to prevent bacterial co-infection.Undoubtedly, the prevalence of antibiotics in the aquatic environment will ultimately affect the degree of resistance against these bacteria in animals and the environmental systems. In order to monitor 16 cephalosporins in the aquatic environment, we developed a new liquid chromatography-tandem mass spectrometry method that functioned simultaneously under positive and negative electrospray ionization switching modes. The chromatographic separation has been implemented using a pentafluorophenyl propyl column kept at 40 • C. The limits of detection and quantitation for the studied cephalosporins ranged from (8 × 10 −4 ) to (7.11 × 10 −2 ) ng/ml and from (2.61 × 10 −3 ) to (2.37 × 10 −1 ) ng/ml, respectively. The percent extraction efficiency (apparent recovery) and relative standard deviations for the analyzed cephalosporins ranged from 61.69% to 167.67% and 2.45% to 13.48%, respectively. The overall findings showed that the effluent from the wastewater treatment plants that receive wastewater from pharmaceutical factories had a higher detected amount of cephalosporins than that of domestic sewage. Moreover, seven cephalosporins, including cefuroxime, ceftazidime, cefradine, cefprozil, cefixime, cefalexin, and cefadroxil (0.68-105.45 ng/L) were determined in the aquatic environment.

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Simultaneous quantification of cefpodoxime proxetil and clavulanic acid in human plasma by LC–MS using solid phase extraction with application to pharmacokinetic studies

Cited by 15 publications

References 17 publications

A sensitive and high‐throughput quantitative liquid chromatography high‐resolution mass spectrometry method for therapeutic drug monitoring of 10 β‐lactam antibiotics, linezolid and two β‐lactamase inhibitors in human plasma

A sensitive and high‐throughput quantitative liquid chromatography high‐resolution mass spectrometry method for therapeutic drug monitoring of 10 β‐lactam antibiotics, linezolid and two β‐lactamase inhibitors in human plasma

Recent bioanalytical methods for quantification of third‐generation cephalosporins using HPLC and LC‐MS(/MS) and their applications in pharmacokinetic studies

Quantification of 16 cephalosporins in the aquatic environment by liquid chromatography‐tandem mass spectrometry

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