一种新型高效液相色谱法测定人血浆中的西来昔帕并将其应用于原型药代动力学研究

IF 16.4 1区 化学 Q1 CHEMISTRY, MULTIDISCIPLINARY
Burhan Ceylan, Gizem Tırıs, Ş. E. KEPEKÇİ TEKKELİ, C. Önal, A. Önal
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引用次数: 0

摘要

本研究介绍了一种简便、经济的新型高效液相色谱技术,用于定量检测人体血浆样品中的西来昔布(SLP),并将该技术应用于药物动力学研究。色谱分离采用 C18(5 µm × 4.6 mm × 150 mm)色谱柱,温度为 30 °C,等度洗脱,流动相为溶液 A(乙腈)和溶液 B(0.5% 甲酸)(65:35 v/v),流速为 1.2 mL min-1。线性范围为 10-150 纳克 mL-1。样品制备步骤是用乙腈沉淀人血浆,在 300 nm 波长下检测。保留时间为 8.20 ± 0.02 分钟。药物的检测限为 3.3 ng mL-1。该方法用于分析人血浆中的 SLP,回收率为 97.83%。根据 EMA 准则对所研究的方法进行了验证。新方法应用于一项原型药代动力学研究,即给一名健康志愿者服用 800 μg SLP,评估了 AUC0-24、AUC0-∞、Cmax、tmax 和 t1/2 等参数。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A novel HPLC method for selexipag in human plasma and application to a prototype pharmacokinetic study
A novel simple and cost effective HPLC technique was presented for the quantification of selexipag (SLP) in human plasma sample and the technique's applicability to a pharmacokinetic investigation. Chromatographic separation was achieved with C18 (5 µm × 4.6 mm × 150 mm) column, at 30 °C with isocratic elution, mobile phase composed of solution A (acetonitrile), and solution B (0.5% formic acid) (65:35 v/v) at flow rate 1.2 mL min−1. The linearity range is 10–150 ng mL−1. As sample preparation step human plasma was precipitated with acetonitrile and the detection was provided at 300 nm. The retention time is 8.20 ± 0.02 min. LOD is found to be 3.3 ng mL−1 for drug. The method was applied to the analysis of SLP in human plasma with good recovery as 97.83%. Validation of the studied methods was carried out according to EMA guideline. The new method applied on a prototype pharmacokinetic study by administration of 800 μg SLP to a healthy volunteer and parameters like AUC0–24, AUC0–∞, Cmax, tmax, and t1/2 were assessed.
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来源期刊
Accounts of Chemical Research
Accounts of Chemical Research 化学-化学综合
CiteScore
31.40
自引率
1.10%
发文量
312
审稿时长
2 months
期刊介绍: Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.
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