%0 Journal Article
%T Development, validation, and clinical application of a UPLC-MS/MS method for omadacycline determination in human serum.
%A Suhang G
%A Ren Z
%A Xudong F
%A Ruoying Z
%A Xinjun C
%A Jie J
%J J Pharmacol Toxicol Methods
%V 127
%N 0
%D 2024 May-Jun 3
%M 38574874
%F 2.285
%R 10.1016/j.vascn.2024.107503
%X <B>BACKGROUND: </B>Omadacycline is the first aminomethyl-tetracycline variety to successfully enter clinical applications. To support regular therapeutic drug monitoring (TDM) in clinical practice, an ultra-high-performance liquid chromatography coupled with tandem mass spectrometry (UPLC-MS/MS) method was developed that would allow omadacycline quantification in human serum.<BR><B>METHODS: </B>Proteins were precipitated from serum samples using methanol. Tigecycline was used as the internal standard. Mobile phase A was formic acid in water (0.1% v/v) and mobile phase B was methanol. UPLC-MS/MS was performed for analyte separation using a gradient elution program at a flow rate of 0.3 mL/min and a total run time of 5 min. The chromatography column was a ZORBAX PRHD SB-Aq (3 × 50 mm, 1.8 μm, Agilent, USA). The multiple reaction monitoring transitions at m/z = 557.4/470.3 and 586.5/513.3 were selected for omadacycline and tigecycline in the positive mode, respectively.<BR><B>RESULTS: </B>The validated curve ranges were 0.5-25.0 μg/mL. This method exhibited acceptable selectivity, matrix effects, and recovery. The inter- and intra-run accuracies ranged from 93.5% to 114.8%, and the inter- and intra-run precisions were between 1.29% and 5.55%.<BR><B>CONCLUSIONS: </B>The LC-MS/MS method provided a simple, specific, and rapid quantification of omadacycline in the serum of patients with pulmonary infection.