A Direct Injection Technique to Improve Biosafety to Analyze Levetiracetam Concentrations in Human Serum and Its Application in Therapeutic Drug Monitoring. Issue 2 (April 2021)

• Record Type: Journal Article
• Authors: Dong, Wei-chong; Guo, Jia-liang; Yang, Xiu-ling; Wang, Shu-mei; Yuan, Ye; Zhao, Meng-qiang; Jiang, Ye; Zhang, Zhi-qing
• Is Part Of: Therapeutic drug monitoring. Volume 43:Issue 2(2021)
• Publication Date: 2021-04
• Subjects: levetiracetam -- hollow fiber -- centrifugal ultrafiltration -- UPLC -- therapeutic drug monitoring; Pharmacokinetics -- Periodicals; Patient monitoring -- Periodicals; Drugs -- Analysis -- Periodicals; Body fluids -- Analysis -- Periodicals; Drug Therapy -- Periodicals; Monitoring, Physiologic -- Periodicals; Pharmacology -- Periodicals; 615.7
• DOI: 10.1097/FTD.0000000000000802
• Languages: English
• ISSNs: 0163-4356

Abstract

Abstract : Background: With the outbreak of COVID-19, it has become very important to improve biosafety measures taken by medical staff. Fewer pretreatment steps correspond to lower chances of infection. The authors established a direct injection technique to analyze levetiracetam (LEV) concentrations in human serum and studied its application in therapeutic drug monitoring. Methods: Serum samples were prepared by hollow fiber centrifugal ultrafiltration and the filtrate was directly injected into a ultra-high performance liquid chromatography apparatus (Waters UPLC BEH C18 column: 50 × 2.1 mm, 1.7 μm) for analysis. The mobile phase consisted of acetonitrile and water (8:92) at a flow rate of 1.0 mL/min. The column temperature was maintained at 30°C. The detected wavelength was 210 nm. Results: A linear relationship was obtained for LEV from 0.625 to 80 mcg/mL ( r 2 = 0.999). The limit of detection for the analysis of LEV was 0.125 mcg/mL. The analysis time was shortened to 4 minutes. The recovery rate of LEV based on the current method was 96.6%–100.1%, whereas the absolute recovery rate was 93.2%–96.8%. The relative SD of intraday and interday precision was <7.3%. Stability was achieved at room temperature for 24 hours after 3 freeze–thaw cycles and at −80°C for 21 days. The method was successfully applied to determine LEV concentrations in the serum of 19 patients. Conclusions: The present method is simple, accurate, and sensitive, and can improve biosafety with the direct injection technique. It is suitable for the analysis of LEV concentrations in therapeutic drug monitoring.