大鼠血浆中恩杂鲁胺和瑞格列奈的DoE辅助高效液相色谱法开发与验证。

IF 1.9 4区 医学 Q3 BIOCHEMICAL RESEARCH METHODS
Bioanalysis Pub Date : 2024-01-01 Epub Date: 2024-08-08 DOI:10.1080/17576180.2024.2383070
Gangireddy Navitha Reddy, Akanksha Jogvanshi, Dannarm Srinivas Reddy, Laltanpuii Chenkual, Rajesh Sonti
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引用次数: 0

摘要

目的:开发并验证一种简单快速的高效液相色谱技术,用于同时测定大鼠血浆中的恩扎鲁胺(ENZ)和瑞格列奈(REP)。方法:使用 DDinter 进行硅预测:利用DDinter和DDI-Pred进行的硅学预测表明,ENZ和REP之间可能存在药物间相互作用。采用中心复合设计确定影响药物分离的因素。通过 51 次实验研究了色谱参数之间的相互作用,然后用三维响应面图进行了说明。柱温(A)、有机物浓度(B)、pH 值(C)和柱型(D)这四个因素对两种药物的分离起到了优化作用。结果分析了实验设计中的板数(R1)、拖尾因子(R2)和分辨率(R3)响应,预测的有利色谱条件为以 0.1% 甲酸和乙腈为流动相,Phenomenex C18 LC 色谱柱(250 × 4.6 mm,5 μm)。该方法采用简单的蛋白质沉淀步骤估算了大鼠血浆中的药物含量,结果表明ENZ和REP的线性范围分别为0.5~16和5~50 μg/ml,准确度和精密度良好。结论优化后的方法可用于未来药物定量和药物相容性研究的生物分析工作流程中。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
DoE-assisted HPLC method development and validation of enzalutamide and repaglinide in rat plasma.

Aim: A simple and rapid HPLC technique was developed and validated to simultaneously estimate enzalutamide (ENZ) and repaglinide (REP) in rat plasma.Methods: In silico predictions using DDinter and DDI-Pred indicated possible drug-drug interactions between ENZ and REP. A central composite design was used to identify factors influencing the separation of the drugs. Interactions between chromatographic parameters were studied through 51 experiments, followed by illustration with three-dimensional response surface plots. The four factors optimized for the separation of the two drugs are column temperature (A), % organic strength (B), pH (C) and column type (D).Results: Plate count(R1), tailing factor (R2) and resolution (R3) responses in the experimental design were analyzed with the favorable chromatographic conditions predicted to be 0.1% formic acid and acetonitrile as mobile phases on a Phenomenex C18 LC column (250 × 4.6 mm, 5 μm). The method was applied to estimate the drugs in rat plasma using a simple protein-precipitation step and found to be linear, accurate and precise within the ranges of 0.5-16 and 5-50 μg/ml for ENZ and REP, respectively.Conclusion: The optimized method can be used in future bioanalytical workflow for drug quantification and drug-drug compatible studies.

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来源期刊
Bioanalysis
Bioanalysis BIOCHEMICAL RESEARCH METHODS-CHEMISTRY, ANALYTICAL
CiteScore
3.30
自引率
16.70%
发文量
88
审稿时长
2 months
期刊介绍: Reliable data obtained from selective, sensitive and reproducible analysis of xenobiotics and biotics in biological samples is a fundamental and crucial part of every successful drug development program. The same principles can also apply to many other areas of research such as forensic science, toxicology and sports doping testing. The bioanalytical field incorporates sophisticated techniques linking sample preparation and advanced separations with MS and NMR detection systems, automation and robotics. Standards set by regulatory bodies regarding method development and validation increasingly define the boundaries between speed and quality. Bioanalysis is a progressive discipline for which the future holds many exciting opportunities to further reduce sample volumes, analysis cost and environmental impact, as well as to improve sensitivity, specificity, accuracy, efficiency, assay throughput, data quality, data handling and processing. The journal Bioanalysis focuses on the techniques and methods used for the detection or quantitative study of analytes in human or animal biological samples. Bioanalysis encourages the submission of articles describing forward-looking applications, including biosensors, microfluidics, miniaturized analytical devices, and new hyphenated and multi-dimensional techniques. Bioanalysis delivers essential information in concise, at-a-glance article formats. Key advances in the field are reported and analyzed by international experts, providing an authoritative but accessible forum for the modern bioanalyst.
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