A simple, high-throughput and validated LC-MS/MS method for the determination of azithromycin in human plasma and its application to a clinical pharmacokinetic study.

Autor: Zhang Y; Clinical Pharmacology Laboratory, Department of Pharmacy Practice and Science, College of Pharmacy, University of Nebraska Medical Center, Omaha, NE, USA.; Department of Pharmacy, Nanfang Hospital, Southern Medical University, Guangzhou, China., Bala V; Clinical Pharmacology Laboratory, Department of Pharmacy Practice and Science, College of Pharmacy, University of Nebraska Medical Center, Omaha, NE, USA., Chhonker YS; Clinical Pharmacology Laboratory, Department of Pharmacy Practice and Science, College of Pharmacy, University of Nebraska Medical Center, Omaha, NE, USA., Aldhafiri WN; Clinical Pharmacology Laboratory, Department of Pharmacy Practice and Science, College of Pharmacy, University of Nebraska Medical Center, Omaha, NE, USA.; Department of Pharmaceutical Science, College of Pharmacy, University of Nebraska Medical Center, Omaha, NE, USA., John LN; National Department of Health, Port Moresby, Papua New Guinea.; University of Barcelona, Barcelona, Spain.; School of Medicine and Health Sciences, University of Papua New Guinea, Port Moresby, Papua New Guinea., Bjerum CM; Center for Global Health and Diseases, Case Western Reserve University, Cleveland, OH, USA., King CL; Center for Global Health and Diseases, Case Western Reserve University, Cleveland, OH, USA.; Veterans Affairs Medical Center, Cleveland, OH, USA., Mitja O; University of Barcelona, Barcelona, Spain.; School of Medicine and Health Sciences, University of Papua New Guinea, Port Moresby, Papua New Guinea., Marks M; London School of Hygiene and Tropical Medicine, London, UK.; Hospital for Tropical Diseases, London, UK.; Division of Infection and Immunity, University College London, London, UK., Murry DJ; Clinical Pharmacology Laboratory, Department of Pharmacy Practice and Science, College of Pharmacy, University of Nebraska Medical Center, Omaha, NE, USA.; Fred and Pamela Buffett Cancer Center, University of Nebraska Medical Center, Omaha, NE, USA.
Jazyk: angličtina
Zdroj: Biomedical chromatography : BMC [Biomed Chromatogr] 2022 Oct; Vol. 36 (10), pp. e5443. Date of Electronic Publication: 2022 Jul 19.
DOI: 10.1002/bmc.5443
Abstrakt: A sensitive, specific and rapid liquid chromatographic-tandem mass spectrometric (LC-MS/MS) method was developed and validated to quantify azithromycin concentrations in human plasma. Azithromycin (AZI) is the most common outpatient prescribed antibiotic in the US and clinical studies have demonstrated the efficacy and safety of AZI in many bacterial infections. To support a clinical study, we developed a high-throughput LC-MS/MS method to process up to 250 samples per day to quantify AZI in human plasma. Samples were prepared by solid-phase extraction. Separation was achieved with an ACE C 18 column (2.1 × 100 mm, 1.7 μm) equipped with a C 18 guard column. The mobile phase consisted of 0.1% formic acid and methanol-acetonitrile (1:1, v/v) at a flow rate of 0.25 ml/min. The ionization was optimized with positive electrospray source using multiple reaction monitoring transition, m/z 749.50 > 591.45 for AZI and m/z 754.50 > 596.45 for AZI-d5. Extraction recoveries were approximately 90% for AZI. The assay was linear from 0.5 to 2,000 ng/ml and required only 100 μl of plasma with a total analysis time of 4.5 min. The method was successfully applied to pharmacokinetic studies of a weight-based dosing protocol for AZI.
(© 2022 The Authors. Biomedical Chromatography published by John Wiley & Sons Ltd.)
Databáze: MEDLINE
Externí odkaz: