Guo Suhang, Zheng Ren, Fan Xudong, Zhang Ruoying, Cai Xinjun, Jin Jie
{"title":"用于测定人血清中奥美拉唑霉素含量的 UPLC-MS/MS 方法的开发、验证和临床应用","authors":"Guo Suhang, Zheng Ren, Fan Xudong, Zhang Ruoying, Cai Xinjun, Jin Jie","doi":"10.1016/j.vascn.2024.107503","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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% <em>v</em>/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 <em>m</em>/<em>z</em> = 557.4/470.3 and 586.5/513.3 were selected for omadacycline and tigecycline in the positive mode, respectively.</p></div><div><h3>Results</h3><p>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%.</p></div><div><h3>Conclusions</h3><p>The LC-MS/MS method provided a simple, specific, and rapid quantification of omadacycline in the serum of patients with pulmonary infection.</p></div>","PeriodicalId":16767,"journal":{"name":"Journal of pharmacological and toxicological methods","volume":null,"pages":null},"PeriodicalIF":1.3000,"publicationDate":"2024-04-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.sciencedirect.com/science/article/pii/S1056871924000133/pdfft?md5=77c128b8fb7e30cf28beaa97ba83add5&pid=1-s2.0-S1056871924000133-main.pdf","citationCount":"0","resultStr":"{\"title\":\"Development, validation, and clinical application of a UPLC-MS/MS method for omadacycline determination in human serum\",\"authors\":\"Guo Suhang, Zheng Ren, Fan Xudong, Zhang Ruoying, Cai Xinjun, Jin Jie\",\"doi\":\"10.1016/j.vascn.2024.107503\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><h3>Background</h3><p>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.</p></div><div><h3>Methods</h3><p>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% <em>v</em>/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 <em>m</em>/<em>z</em> = 557.4/470.3 and 586.5/513.3 were selected for omadacycline and tigecycline in the positive mode, respectively.</p></div><div><h3>Results</h3><p>The validated curve ranges were 0.5–25.0 μg/mL. 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Development, validation, and clinical application of a UPLC-MS/MS method for omadacycline determination in human serum
Background
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.
Methods
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.
Results
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%.
Conclusions
The LC-MS/MS method provided a simple, specific, and rapid quantification of omadacycline in the serum of patients with pulmonary infection.
期刊介绍:
Journal of Pharmacological and Toxicological Methods publishes original articles on current methods of investigation used in pharmacology and toxicology. Pharmacology and toxicology are defined in the broadest sense, referring to actions of drugs and chemicals on all living systems. With its international editorial board and noted contributors, Journal of Pharmacological and Toxicological Methods is the leading journal devoted exclusively to experimental procedures used by pharmacologists and toxicologists.