Pharmacokinetic profile and incurred sample stability of hydroxychloroquine in Volumetric Absorptive Microsampling (VAMS) using high-performance liquid chromatography-photodiode array

IF 0.5 Q4 EDUCATION, SCIENTIFIC DISCIPLINES

Pharmacy Education Pub Date : 2024-06-14 DOI:10.46542/pe.2024.246.116123

Gregorio Fernando Hadi, Y. Harahap, Sunarsih

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引用次数: 0

Abstract

Background: Hydroxychloroquine (HCQ) is a quinoline compound derived from chloroquine used to treat SLE. An in vitro stability evaluation was conducted to develop and validate the hydroxychloroquine analysis method. However, an assessment of the incurred sample stability is needed to ensure drug effectiveness, as in vitro evaluation doesn't reflect drug metabolism processes in the body. Objective: This research aims to obtain a pharmacokinetic profile of hydroxychloroquine using Volumetric Absorptive Microsampling (VAMS) as a safe sampling technique to use during the COVID-19 pandemic and evaluate the incurred sample stability of hydroxychloroquine samples. Methods: The chromatographic conditions used were column C18 (Waters, XBridge; 250 × 4.6 mm; 5μm); mobile phase acetonitrile-1% diethylamine (65:35); flow rate of 0.8 mL/min; column temperature 45°C; PDA detector analysis wavelength of 332 nm; and chloroquine as internal standard. Results: The pharmacokinetic profile of hydroxychloroquine in VAMS samples gave results that the Cmax ranged from 322.61-505.32 ng/mL with an average of 425.33 ± 65.90 ng/mL; tmax was 4 hours; mean t1/2 was 23.32 ± 9.65 hours; mean AUC0-72 was 5103.63 ± 1419.66 ng.h/mL; mean AUC0-∞ was 5763.97 ± 2155.26 ng.h/mL, and the AUC ratio was above 80%. Conclusion: The incurred sample stability of hydroxychloroquine in VAMS met the 2011 EMEA Bioanalytical Guideline requirements up to day 30.

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使用高效液相色谱-光电二极管阵列进行体积吸收微量采样 (VAMS) 中羟氯喹的药代动力学特征和产生的样品稳定性

背景：羟氯喹（HCQ）是一种从氯喹中提取的喹啉化合物，用于治疗系统性红斑狼疮。为开发和验证羟氯喹分析方法，进行了体外稳定性评估。然而，由于体外评估不能反映药物在体内的代谢过程，因此需要对产生的样品进行稳定性评估，以确保药物的有效性：本研究旨在利用体积吸收微量采样（VAMS）技术获得羟氯喹的药代动力学曲线，作为 COVID-19 大流行期间使用的安全采样技术，并评估羟氯喹样品的稳定性：色谱条件：色谱柱 C18（Waters，XBridge；250 × 4.6 mm；5μm）；流动相乙腈-1%二乙胺（65:35）；流速 0.8 mL/min；柱温 45°C；PDA 检测器分析波长 332 nm；氯喹为内标：VAMS 样品中羟氯喹的药代动力学曲线显示，Cmax 在 322.61-505.32 ng/mL 之间，平均值为 425.33 ± 65.90纳克/毫升；tmax为4小时；平均t1/2为23.32±9.65小时；平均AUC0-72为5103.63±1419.66纳克.小时/毫升；平均AUC0-∞为5763.97±2155.26纳克.小时/毫升，AUC比值在80%以上：结论：在VAMS中，羟氯喹的进样稳定性在第30天之前都符合2011年欧洲药品管理局生物分析指南的要求。

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来源期刊

Pharmacy Education EDUCATION, SCIENTIFIC DISCIPLINES-

CiteScore

0.80

自引率

20.00%

发文量

174

期刊介绍： Pharmacy Education journal provides a research, development and evaluation forum for communication between academic teachers, researchers and practitioners in professional and pharmacy education, with an emphasis on new and established teaching and learning methods, new curriculum and syllabus directions, educational outcomes, guidance on structuring courses and assessing achievement, and workforce development. It is a peer-reviewed online open access platform for the dissemination of new ideas in professional pharmacy education and workforce development. Pharmacy Education supports Open Access (OA): free, unrestricted online access to research outputs. Readers are able to access the Journal and individual published articles for free - there are no subscription fees or ''pay per view'' charges. Authors wishing to publish their work in Pharmacy Education do so without incurring any financial costs.