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Updated: Apr 3, 2026
Multiplex Therapeutic Drug Monitoring by Isotope-dilution HPLC-MS/MS of Antibiotics in Critical Illnesses
Published on: August 30, 2018
An UHPLC-MS/MS method for the simultaneous determination of ampicillin and sulbactam in human plasma and urine
Suzanne L Parker1, Syamhanin Adnan2, Jenny L Ordóñez Meija1
1Burns, Trauma & Critical Care Research Centre, The University of Queensland, Brisbane, Australia.
Background:
With few new antibiotics available and an increased prevalence of multidrug-resistant bacteria, optimizing the effectiveness of currently available antibiotics and minimizing the potential for emerging resistance, through PK characterization, is of paramount importance.
Results:
Inter- and intra-assay results for ampicillin were within 5% for accuracy and 7% for precision, and for sulbactam within 7% for accuracy and 7% for precision, for both plasma and urine. The plasma Cmax was 38.4 µg/ml for ampicillin and 19.0 µg/ml for sulbactam. The urine concentrations were 668 µg/ml for ampicillin and 438 µg/ml for sulbactam.
Conclusion:
An UHPLC-MS/MS method to simultaneously measure co-formulated ampicillin and sulbactam in plasma and urine, for use in a patient PK study, has been developed and validated.
Insights
A new method accurately measures ampicillin and sulbactam concentrations in patient samples. This pharmacokinetic (PK) characterization is crucial for optimizing antibiotic effectiveness and combating drug resistance.
Area of Science:
- Pharmacology
- Analytical Chemistry
- Microbiology
Background:
- Rising prevalence of multidrug-resistant bacteria necessitates optimizing current antibiotic effectiveness.
- Limited development of new antibiotics underscores the importance of understanding existing drug pharmacokinetics (PK).
- PK characterization is vital for minimizing emerging antibiotic resistance.
Purpose of the Study:
- To develop and validate a method for simultaneously measuring ampicillin and sulbactam.
- To support pharmacokinetic studies in patients receiving co-formulated ampicillin and sulbactam.
Main Methods:
- Ultra-High-Performance Liquid Chromatography-Tandem Mass Spectrometry (UHPLC-MS/MS) was employed.
- The method was validated for accuracy and precision in plasma and urine matrices.
- Simultaneous quantification of ampicillin and sulbactam was performed.
Main Results:
- Assay accuracy was within 5% for ampicillin and 7% for sulbactam.
- Assay precision was within 7% for both ampicillin and sulbactam.
- Achieved plasma Cmax: ampicillin 38.4 µg/ml, sulbactam 19.0 µg/ml; urine concentrations: ampicillin 668 µg/ml, sulbactam 438 µg/ml.
Conclusions:
- A validated UHPLC-MS/MS method enables simultaneous measurement of ampicillin and sulbactam.
- This method is suitable for pharmacokinetic studies in patients.
- The findings contribute to optimizing antibiotic therapy and managing resistance.
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