A Simple HPLC-UV Method for Ivosidenib Determination in Human Plasma.

IF 1.5 4区化学 Q4 BIOCHEMICAL RESEARCH METHODS

Journal of chromatographic science Pub Date : 2024-07-10 DOI:10.1093/chromsci/bmad082

Yoshito Gando, Takeo Yasu

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引用次数: 0

Abstract

Ivosidenib is used for the treatment of acute myeloid leukemia (AML) with isocitrate dehydrogenase 1 (IDH1) mutations. However, increased blood concentrations of ivosidenib are associated with a risk of a prolonged QT interval in patients with AML. Therapeutic drug monitoring in patients with AML with IDH1 mutation offers the potential to improve treatment efficacy while minimizing toxicity. In this study, we developed an efficient high-performance liquid chromatography-ultraviolet (HPLC-UV) method for the quantification of ivosidenib in plasma. Human plasma samples (50 μL) were processed by protein precipitation using acetonitrile, followed by chromatographic separation on a reversed-phase column with an isocratic mobile phase of 0.5% KH₂PO₄ (pH 4.5) and acetonitrile (45:55, v/v) at a flow rate of 1.0 mL/min, with ultraviolet detection at 245 nm. Calibration curves were linear over the range of 0.25-20 μg/mL with a coefficient of determination (r2) of 0.99999. Intra-day and inter-day precision were 1.20-8.04% and 0.69-4.20%, respectively. The assay accuracy was -2.00% to 1.93% and recovery was >91.2%. These findings support the effectiveness of the newly developed HPLC-UV method for the quantification of ivosidenib in human plasma. This simple and cost-effective method is expected to expand ivosidenib monitoring in laboratories lacking LC-MS/MS instruments.

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高效液相色谱-紫外分光光度法测定人血浆中艾沃西替尼的含量。

Ivosidenib用于治疗具有异柠檬酸脱氢酶1（IDH1）突变的急性髓系白血病（AML）。然而，伊沃西替尼血药浓度升高与AML患者QT间期延长的风险相关。IDH1突变AML患者的治疗药物监测有可能提高治疗效果，同时将毒性降至最低。在本研究中，我们开发了一种高效液相色谱-紫外（HPLC-UV）方法来定量血浆中的伊沃西替尼。使用乙腈通过蛋白质沉淀处理人血浆样品（50μL），然后在反相柱上用0.5%KH的等度流动相进行色谱分离₂PO₄ （pH 4.5）和乙腈（45:55，v/v），流速为1.0mL/min，紫外检测波长为245nm。校准曲线在0.25-20μg/mL范围内呈线性，测定系数（r2）为0.99999。日内和日间精密度分别为1.20-8.04%和0.69-4.20%。测定准确度为-2.00%至1.93%，回收率>91.2%。这些发现支持了新开发的HPLC-UV方法对人血浆中伊沃西替尼的定量有效性。这种简单且具有成本效益的方法有望扩大缺乏LC-MS/MS仪器的实验室对伊沃西替尼的监测。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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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.