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A New HPLC Method with UV Detection for the Determination of Carnosol in Human Plasma and Application to a Pharmacokinetic Study
Chromatographia ( IF 1.2 ) Pub Date : 2021-08-04 , DOI: 10.1007/s10337-021-04069-0
Burhan Ceylan 1 , Gizem Tırıs 2 , S. Evrim Kepekci Tekkeli 2
Affiliation  

This article aims to present a simple and sensitive, HPLC–UV method, which was developed to determine carnosol in human plasma samples. Chromatographic separation was achieved with C18 column (150 mm × 4.6 mm × 5 μm), at 25 °C with gradient elution of the mobile phase consisting of methanol–water (2% o-phosphoric acid) at flow rate 1.2 mL/min. The analyte was detected at 230 nm by UV detector. The retention time of carnosol is 3.40 ± 0.01 min. This currently developed method was validated according to ICH criteria by evaluating the specificity, linearity, precision, accuracy and robustness. The method was determined to be linear in a concentration range of 1–20 ng/mL with the correlation coefficient of 0.9942. The proposed method was applied successfully to the analysis of carnosol in spiked human plasma with good recovery as 96.4% and the precision of the method was determined by intra day and interday assays with the highest RSD % values 5.71. The method successfully applied to a pharmacokinetic study with determination of Cmax, tmax, t1/2 and AUC, by administration of carnosol to a healthy volunteer.



中文翻译:

一种新型 HPLC 紫外检测法测定人血浆中鼠尾草酚的含量及其在药代动力学研究中的应用

本文旨在介绍一种简单而灵敏的 HPLC-UV 方法,该方法用于测定人血浆样品中的鼠尾草酚。色谱分离是使用 C18 柱(150 mm × 4.6 mm × 5 μm)在 25 °C 下用甲醇-水(2% o-磷酸),流速为 1.2 mL/min。通过紫外检测器在 230 nm 处检测分析物。鼠尾草酚的保留时间为 3.40 ± 0.01 分钟。这种目前开发的方法根据 ICH 标准通过评估特异性、线性、精密度、准确度和稳健性进行了验证。确定该方法在 1–20 ng/mL 的浓度范围内呈线性,相关系数为 0.9942。所提出的方法成功应用于加标人血浆中鼠尾草酚的分析,回收率高达 96.4%,该方法的精密度由日内和日间测定确定,最高 RSD % 值为 5.71。该方法成功应用于药代动力学研究,测定C max , t max , t1/2和 AUC,通过向健康志愿者施用鼠尾草醇。

更新日期:2021-08-10
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