HPLC-based quantitative assessment of antiviral agents in artificial saliva.

IF 2.4 4区医学 Q3 CHEMISTRY, MEDICINAL

Drug Development and Industrial Pharmacy Pub Date : 2025-06-18 DOI:10.1080/03639045.2025.2519977

Aysun Dinçel, Feyyaz Onur

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引用次数: 0

Abstract

Background: The efficient analytical method for antiviral drug quantification is crucial in pharmaceutical and biomedical research, particularly for ensuring accurate dosage and monitoring therapeutic efficacy. Accurate quantification of these compounds in artificial saliva is essential for pharmacokinetic studies, as saliva-based drug monitoring offers a noninvasive alternative to traditional blood sampling.

Objective: A novel high-performance liquid chromatographic (HPLC) method for simultaneous analysis of three selected antivirals: Tenofovir Disoproxil Fumarate (TDF), Favipiravir (FAV), Ritonavir (RIT) and internal standard as another antiviral (emtricitabine) in artificial saliva was optimized and validated, including sample preparation using new extraction procedure.

Methods: The chromatographic separation was achieved with XTerra, C18 (250 × 4.6 mm, 3.5 µm) analytical column (20 °C) at a wavelength of 215 nm, and the mobile phase was composed of 0.1% phosphoric acid, methanol, and an acetonitrile mixture; 32:60:8 (v/v) at a flow rate of 0.8 mL/min. The method was linear over the range of 0.1-1.0 µg/mL.

Results: The method has been found according to ICH guidelines specific, accurate (recovery, 93.003%-103.357%), sensitive (LOD and LOQ were values found as 0.03 and 0.1 µg/mL, respectively), and precise (RSD; 0.412%-3.175%).

Conclusion: A validated HPLC method was developed for the precise determination of different antiviral agents in artificial saliva.

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基于高效液相色谱的人工唾液中抗病毒药物的定量评价。

背景：高效的抗病毒药物定量分析方法在制药和生物医学研究中至关重要，特别是对于确保准确的剂量和监测治疗效果。由于基于唾液的药物监测为传统的血液采样提供了一种非侵入性的替代方法，因此对人工唾液中这些化合物的准确定量对于药代动力学研究至关重要。目的：建立高效液相色谱（HPLC）同时分析人工唾液中富马酸替诺福韦二氧吡酯（TDF）、法匹拉韦（FAV）、利托那韦（RIT）和内标中另一种抗病毒药物恩曲他滨（emtricitabine）的方法，包括采用新的提取工艺制备样品。方法：采用XTerra， C18 （250 × 4.6 mm, 3.5µm）色谱柱（20℃），波长为215 nm，流动相为0.1%磷酸、甲醇和乙腈混合物；32:60:8 (v/v)，流速为0.8 mL/min。该方法在0.1 ~ 1.0µg/mL范围内呈线性。结果：该方法符合ICH指南，特异、准确（回收率为93.003% ~ 103.357%）、灵敏（定量限和定量限分别为0.03和0.1µg/mL）、精确(RSD；0.412% - 3.175%)。结论：建立了一种有效的高效液相色谱法，可精确测定人工唾液中不同抗病毒药物的含量。

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

Drug Development and Industrial Pharmacy 医学-药学

CiteScore

6.80

自引率

0.00%

发文量

审稿时长

4.5 months

期刊介绍： The aim of Drug Development and Industrial Pharmacy is to publish novel, original, peer-reviewed research manuscripts within relevant topics and research methods related to pharmaceutical research and development, and industrial pharmacy. Research papers must be hypothesis driven and emphasize innovative breakthrough topics in pharmaceutics and drug delivery. The journal will also consider timely critical review papers.