Determination of Robenacoxib in Plasma Using Reverse-Phase Liquid Chromatography

IF 1.2 4区化学 Q4 BIOCHEMICAL RESEARCH METHODS Chromatographia Pub Date : 2024-07-23 DOI:10.1007/s10337-024-04351-x

Sherry Cox, Melissa Fayette, David Minch, Joan Bergman

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Abstract

The aim of this paper was to present a rapid, simple, and straightforward high-performance liquid chromatography (HPLC) method for the determination of robenacoxib in plasma. Robenacoxib is a member of the COXIB group of nonsteroidal anti-inflammatory drugs developed for veterinary use. The method was validated based on the FDA Guidance for Industry: Bioanalytical Method Validation for selectivity, linearity, accuracy, precision, stability, and recovery. Methylene chloride was used in a liquid–liquid extraction that produced an average recovery of 97%. Chromatographic separation occurred on a Sunfire C₁₈ column (4.6 × 150 mm) using an isocratic combination of 0.025% trifluoroacetic acid in water and acetonitrile (50:50, v/v). Ultraviolet absorbance was measured at 275 nm and the flow rate was 1.1 mL/min. The method was linear in the concentration range of 0.1 to 50 µg/mL. The assay variability ranged from 2.2% to 9.2% while the accuracy was 100%. The lower limit of quantification for a 0.1 mL sample size was 0.1 µg/mL. The method was used for the determination of robenacoxib in plasma samples.

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用反相液相色谱法测定血浆中的罗苯那考昔

本文旨在介绍一种快速、简单、直接的高效液相色谱（HPLC）方法，用于测定血浆中的罗苯昔布。罗贝拉昔布是COXIB类非甾体抗炎药中的一种，开发用于兽药。该方法根据 FDA 行业指南进行验证：对该方法的选择性、线性、准确性、精密度、稳定性和回收率进行了验证。液液萃取中使用了二氯甲烷，平均回收率为 97%。色谱分离采用 Sunfire C18 色谱柱（4.6 × 150 毫米），使用 0.025% 三氟乙酸水溶液和乙腈（50:50, v/v）的等度组合。紫外吸光度在 275 纳米波长处测定，流速为 1.1 mL/min。该方法在 0.1 至 50 µg/mL 浓度范围内线性良好。检测变异率为 2.2% 至 9.2%，准确率为 100%。0.1 mL 样品的定量下限为 0.1 µg/mL。该方法用于测定血浆样品中的罗苯昔布。

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来源期刊

Chromatographia 化学-分析化学

CiteScore

3.40

自引率

5.90%

发文量

103

审稿时长

2.2 months

期刊介绍： Separation sciences, in all their various forms such as chromatography, field-flow fractionation, and electrophoresis, provide some of the most powerful techniques in analytical chemistry and are applied within a number of important application areas, including archaeology, biotechnology, clinical, environmental, food, medical, petroleum, pharmaceutical, polymer and biopolymer research. Beyond serving analytical purposes, separation techniques are also used for preparative and process-scale applications. The scope and power of separation sciences is significantly extended by combination with spectroscopic detection methods (e.g., laser-based approaches, nuclear-magnetic resonance, Raman, chemiluminescence) and particularly, mass spectrometry, to create hyphenated techniques. In addition to exciting new developments in chromatography, such as ultra high-pressure systems, multidimensional separations, and high-temperature approaches, there have also been great advances in hybrid methods combining chromatography and electro-based separations, especially on the micro- and nanoscale. Integrated biological procedures (e.g., enzymatic, immunological, receptor-based assays) can also be part of the overall analytical process.