An analytical method using salting‐out assisted liquid–liquid extraction to quantify ceftriaxone from micro volumes of human serum

Author:

Mukai Yuji1ORCID,Sugii Narushi2,Doki Kosuke13ORCID,Homma Masato13

Affiliation:

1. Department of Pharmacy University of Tsukuba Hospital Tsukuba Ibaraki Japan

2. Department of Neurosurgery, Institute of Medicine University of Tsukuba Tsukuba Ibaraki Japan

3. Department of Pharmaceutical Sciences, Institute of Medicine University of Tsukuba Tsukuba Ibaraki Japan

Abstract

AbstractCeftriaxone (CTRX) is a commonly used cephalosporin antibiotic. It is suggested that monitoring plasma/serum concentrations is helpful for its safe use. This study aimed to develop and validate an analytical method for measuring CTRX concentrations in human serum according to International Conference on Harmonization guideline M10. Ten microliters of serum sample was purified using a salting‐out assisted liquid–liquid extraction procedure with magnesium sulfate. The upper layer was then diluted threefold and analyzed using a liquid chromatography–tandem mass spectrometry‐based method with a total run time of 12 min. The linear calibration curve was obtained over the concentration range 5–500 μg/ml. The within‐run accuracy varied from 0.2 to 6.5%, and the precision was ≤8.0%. The between‐run accuracy and precision ranged from 0.7% to 5.6% and ≤6.4%, respectively. Significant carryover was resolved by injecting four blanks after high‐concentration CTRX samples. The recovery rates from spiked serum at low and high concentrations were 44.4 and 43.4%, respectively. Other factors, including selectivity, matrix effects, stability, dilution integrity and reinjection reproducibility also met the acceptance criteria. Serum concentrations in 14 samples obtained from two participants receiving 2 g/day of CTRX were successfully determined using this method.

Publisher

Wiley

Reference15 articles.

1. Validated HPLC method for ceftriaxone from dried blood spots for pharmacokinetic studies and therapeutic drug monitoring in neonatal population

2. Ceftriaxone versus Other Antibiotics for Surgical Prophylaxis

3. European Medicines Agency. (2022).EMA/CHMP/ICH/172948/2019. ICH guideline M10 on bioanalytical method validation and study sample analysis. Retrieved March 5 2024 fromhttps://www.ema.europa.eu/en/documents/scientific‐guideline/ich‐guideline‐m10‐bioanalytical‐method‐validation‐step‐5_en.pdf

4. Ceftriaxone pharmacokinetics by a sensitive and simple LC–MS/MS method: Development and application

5. Three Cases of Hemodialysis Patients Receiving High-Dose Ceftriaxone: Serum Concentrations and Its Neurotoxicity

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