Evidence map›Paper›PMID 39289803›Full record

ArticleTherapeutic drug monitoring2025

Development and Validation of a High-Performance Liquid Chromatography-Ultraviolet Spectrometry Method for Ampicillin and Its Application in Routine Therapeutic Drug Monitoring of Intensive Care Patients.

Benedict Morath, Linda Schultes, Otto Roman Frey, Anka Christa Röhr, Hannes Christow, Torsten Hoppe-Tichy, Alexander Brinkmann, Ute Chiriac

Abstract readValidation Study
In one paragraph

Article in Therapeutic drug monitoring, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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2 · The registry

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3 · Its place in the literature

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4 · The record

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5 · Who and what money

Authors and funding

8 authors.

Benedict MorathHospital Pharmacy, Heidelberg University Hospital, Heidelberg, Germany; and.
Linda SchultesHospital Pharmacy, General Hospital Heidenheim, Heidenheim, Germany; and.
Otto Roman FreyHospital Pharmacy, General Hospital Heidenheim, Heidenheim, Germany; and.
Anka Christa RöhrHospital Pharmacy, General Hospital Heidenheim, Heidenheim, Germany; and.
Hannes ChristowDepartments of Internal Medicine and Intensive Care Medicine, and.
Torsten Hoppe-TichyHospital Pharmacy, Heidelberg University Hospital, Heidelberg, Germany; and.
Alexander BrinkmannAnaesthesiology and Intensive Care Medicine, General Hospital Heidenheim, Heidenheim, Germany.
Ute ChiriacHospital Pharmacy, Heidelberg University Hospital, Heidelberg, Germany; and.ORCID 0000-0002-4288-1745

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundAmpicillin/sulbactam, a combination of a β-lactam and β-lactamase inhibitor, is widely used in clinical settings. However, therapeutic drug monitoring (TDM) of ampicillin is not commonly performed, particularly in intensive care units (ICUs). The purpose of this study was to develop and validate a rapid and cost-effective high-performance liquid chromatography (HPLC)-ultraviolet spectrometry method to quantify ampicillin in human serum and evaluate its clinical application in ICU patients.

methodsSample cleanup included a protein precipitation protocol, followed by chromatographic separation on a C18 reverse-phase HPLC column within 12.5 minutes using gradient elution of the mobile phase. The assay was validated according to the German Society of Toxicology and Forensic Chemistry criteria. Clinical applications involved the retrospective analysis of TDM data from ICU patients receiving continuous infusion of ampicillin/sulbactam, including the attainment of target ranges and individual predicted and observed pharmacokinetics.

resultsThe method was robust, with linear relations between the peak area responses and drug concentrations in the range of 2-128 mg/L. The coefficient of variation for precision and the bias for accuracy (both interday and intraday) were less than 10%. Clinical application revealed variable pharmacokinetics of ampicillin in ICU patients (clearance of 0.5-31.2 L/h). TDM-guided dose adjustments achieved good therapeutic drug exposure, with 92.9% of the samples being within the optimal (16-32 mg/L) or quasioptimal (8-48 mg/L) range.

conclusionsThis method provides a practical solution for the routine TDM of ampicillin, facilitating individualized dosing strategies to ensure adequate therapeutic drug exposure. Given its simplicity, cost-effectiveness, and clinical relevance, HPLC-ultraviolet spectrometry holds promise for broad implementation in hospital pharmacies and clinical laboratories.

Indexed as

AmpicillinAnti-Bacterial AgentsDrug MonitoringAgedChromatography, High Pressure LiquidCritical CareFemaleHumansIntensive Care UnitsMaleMiddle AgedReproducibility of ResultsRetrospective StudiesSpectrophotometry, UltravioletSulbactamAmpicillinAnti-Bacterial AgentsSulbactamampicillincontinuous infusionhigh-performance liquid chromatography–ultraviolet spectrometrypharmacokinetic/pharmacodynamicstherapeutic drug monitoring

Identifiers

PMID39289803
PMCPMC12061375

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.