Development and Validation of UPLC Tandem Mass Spectrometry Assay for Ceftibuten and Sulbactam in Human Plasma.

IF 1.5 4区化学 Q4 BIOCHEMICAL RESEARCH METHODS Journal of chromatographic science Pub Date : 2024-10-01 DOI:10.1093/chromsci/bmae010

Karla Paulina Valero-Rivera, Martin Magaña-Aquino, María Del Carmen Romero-Méndez, Miriam Nayeli Morales-Barragán, Julia Sagahón-Azúa, Susanna Edith Medellín-Garibay, Rosa Del Carmen Milán-Segovia, Fidel Martínez-Gutiérrez, Silvia Romano-Moreno

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Abstract

A sensitive and rapid ultra-performance liquid chromatography coupled with -tandem mass spectrometry (UPLC-MS/MS) method was developed and validated to determine ceftibuten (CTB) and sulbactam (SUL) in human plasma. An ACQUITY UPLC HSS T3 C18 (2.1 × 100 mm), 1.8 μm column with gradient elution of water (0.1% formic acid) and acetonitrile was used for separation at a flow rate of 0.2 mL/min. This method involves a simple sample preparation with acetonitrile. The calibration curves of CTB and SUL in plasma showed good linearity over the concentration range of 0.50-25 μg/mL and with a correlation coefficient (r2) >0.99. This method was validated in terms of selectivity, linearity, precision, accuracy and stability. High precision was obtained with coefficients of variation <15%. Excellent recovery in the range of 90-104% was achieved for CTB and SUL was 86-110%. The method has the potential utility to support pharmacometric modeling in clinical practice and biopharmaceutic studies.

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人血浆中头孢布坦和舒巴坦的 UPLC 串联质谱分析法的开发与验证

建立并验证了一种灵敏、快速的超高效液相色谱-串联质谱（UPLC-MS/MS）测定人体血浆中头孢布烯（CTB）和舒巴坦（SUL）的方法。采用ACQUITY UPLC HSS T3 C18 (2.1 × 100 mm), 1.8 μm色谱柱，以水（0.1%甲酸）和乙腈为流动相进行梯度洗脱，流速为0.2 mL/min。该方法只需用乙腈进行简单的样品制备。血浆中CTB和SUL的定标曲线在0.50-25 μg/mL浓度范围内线性关系良好，相关系数（r2）大于0.99。该方法在选择性、线性、精密度、准确度和稳定性方面都得到了验证。该方法的选择性、线性、精密度、准确度和稳定性都得到了验证。

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来源期刊

Journal of chromatographic science 化学-分析化学

CiteScore

2.90

自引率

7.70%

发文量

审稿时长

5.6 months

期刊介绍： The Journal of Chromatographic Science is devoted to the dissemination of information concerning all methods of chromatographic analysis. The standard manuscript is a description of recent original research that covers any or all phases of a specific separation problem, principle, or method. Manuscripts which have a high degree of novelty and fundamental significance to the field of separation science are particularly encouraged. It is expected the authors will clearly state in the Introduction how their method compares in some markedly new and improved way to previous published related methods. Analytical performance characteristics of new methods including sensitivity, tested limits of detection or quantification, accuracy, precision, and specificity should be provided. Manuscripts which describe a straightforward extension of a known analytical method or an application to a previously analyzed and/or uncomplicated sample matrix will not normally be reviewed favorably. Manuscripts in which mass spectrometry is the dominant analytical method and chromatography is of marked secondary importance may be declined.