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将织物相吸附萃取法适配为一种创新的多用途工具,用于药代动力学分析中的样品转移和萃取,随后采用液相色谱-质谱联用仪测定血浆样品中的左氧氟沙星。

Adapting Fabric Phase Sorptive Extraction as an Innovative Multitool for Sample Transfer and Extraction in Pharmacokinetic Analysis Followed by LC-MS Determination of Levofloxacin in Plasma Samples.

作者信息

Ekin Dolaksız Yasemin, Kaynak Mustafa Sinan, Kabir Abuzar, Furton Kenneth G, Çelebier Mustafa

机构信息

Faculty of Pharmacy, Department of Analytical Chemistry, Hacettepe University, 06230 Ankara, Turkiye.

Faculty of Pharmacy, Department of Pharmaceutical Technology, Anadolu University, 26460 Eskişehir, Turkiye.

出版信息

ACS Omega. 2024 Apr 15;9(17):18995-19002. doi: 10.1021/acsomega.3c09519. eCollection 2024 Apr 30.

Abstract

Fabric phase sorptive extraction (FPSE) is a simple microextraction technique that allows analytes to be rescued from matrix components while using a small volume of samples to analyze complex biological systems. This study used FPSE as a microextraction tool and a sample storage and transfer device. Levofloxacin as a model molecule was applied intravenously (IV) to New Zealand male rabbits. The samples were simultaneously extracted by using FPSE and protein precipitation methods. The final solutions were analyzed using LC-MS equipped with an ACE C18 LC Column (150 mm × 4.6 mm, 5 μm) at 25 °C employed in isocratic elution mode using solution A (0.1% formic acid in water)/solution B (0.1% formic acid in acetonitrile) (80:20, v/v). The total analysis time was less than 15 min. The developed method was validated using the ICH M10 bioanalytical method validation and study sample analysis guidelines. The results obtained using FPSE were statistically identical to those obtained using protein precipitation. The plasma samples applied onto FPSE (10 μL onto 1.0 cm × 1.0 cm Biofluid Sampler) were stored in three different temperatures [refrigerator (2-8 °C), at ambient temperature (20 ± 5 °C), and in the stability cabinet (40 °C, 75% humidity)] and three different storage conditions (Eppendorf tubes, plastic containers, and straw paper envelopes). Levofloxacin in plasma samples adsorbed by FPSE biofluid sampler remained stable at 2-8 °C in Eppendorf tubes for at least 1 week. This study showed that FPSE could be used as a sample storage and transfer device for pharmacokinetic applications that need to work with small sample volumes and discard aggressive cold chains to store and transfer the plasma samples.

摘要

织物相吸附萃取(FPSE)是一种简单的微萃取技术,它能在使用少量样品分析复杂生物系统的同时,将分析物从基质成分中分离出来。本研究将FPSE用作微萃取工具以及样品储存和转移装置。以左氧氟沙星作为模型分子,通过静脉注射(IV)给予新西兰雄性兔。采用FPSE和蛋白质沉淀法同时对样品进行萃取。最终溶液使用配备ACE C18液相色谱柱(150 mm×4.6 mm,5μm)的液相色谱 - 质谱联用仪进行分析,在25℃下采用等度洗脱模式,流动相为A液(0.1%甲酸水溶液)/B液(0.1%甲酸乙腈溶液)(80:20,v/v)。总分析时间少于15分钟。所建立的方法依据国际人用药品注册技术协调会(ICH)M10生物分析方法验证和研究样品分析指南进行了验证。使用FPSE获得的结果与使用蛋白质沉淀法获得的结果在统计学上无差异。将血浆样品(10μL加至1.0 cm×1.0 cm生物流体采样器上)储存在三种不同温度[冰箱(2 - 8℃)、室温(20±5℃)以及稳定性试验箱(40℃,75%湿度)]和三种不同储存条件[微量离心管、塑料容器和草纸信封]下。被FPSE生物流体采样器吸附的血浆样品中的左氧氟沙星在微量离心管中于2 - 8℃下至少可稳定保存1周。本研究表明,FPSE可作为一种样品储存和转移装置,用于药代动力学应用,这类应用需要处理少量样品,并摒弃用于储存和转移血浆样品的严格冷链要求。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/3ee8/11064165/4b9904a42fd4/ao3c09519_0001.jpg

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