Method validation and determination of pesticides in Mikania glomerta Spreng tincture by direct injection and UPLC-MS/MS analysis

IF 3.1 3区医学 Q2 CHEMISTRY, ANALYTICAL Journal of pharmaceutical and biomedical analysis Pub Date : 2024-10-16 DOI:10.1016/j.jpba.2024.116527

Thais Morais de Brito , Angélica Castanheira de Oliveira , Fabio Coelho Amendoeira , Lucia Helena Pinto Bastos , Maria Helena Wohlers Morelli Cardoso , Leandro Machado Rocha , Armi Wanderley da Nóbrega , Fausto Klabund Ferraris

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Abstract

Over the past two decades, concerns have arisen about the efficacy and safety of medicinal plants, highlighting good agricultural practices and quality control. This study aimed to validate a multi-residue analysis method for detecting 268 pesticides in Mikania glomerata tincture, using direct injection and UPLC-MS/MS, per SANTE guidelines. The validation of the method involved evaluating the linearity of analytical curves in terms of the determination coefficient r2 and residuals (%), as well as the limits of quantification (LOQ), matrix effects, precision (expressed as the coefficient of variation, CV), and accuracy (determined as the recovery percentage). The parameters and acceptance criteria were assessed based on SANTE guidelines. The method was then applied to analyse commercial samples of M. glomerata tincture, and traces of carbendazim and dimethomorph were detected. This study underscores the need for regulatory measures to enhance agricultural practices, thereby ensuring the safety and efficacy of medicinal plants.

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采用直接进样和 UPLC-MS/MS 分析方法验证和测定薇甘菊酊剂中的农药。

在过去的二十年里，人们对药用植物的功效和安全性产生了担忧，这凸显了良好农业规范和质量控制的重要性。本研究旨在根据 SANTE 指南，采用直接进样和超高效液相色谱-质谱/多反应监测（UPLC-MS/MS）技术，验证检测薇甘菊酊中 268 种农药的多残留分析方法。该方法的验证包括以测定系数 r2 和残差（%）评估分析曲线的线性，以及定量限（LOQ）、基质效应、精密度（以变异系数 CV 表示）和准确度（以回收率确定）。参数和验收标准根据 SANTE 指南进行评估。然后将该方法用于分析芒柄菊酊剂的商业样品，结果检测到了痕量的多菌灵和二甲吗啉。这项研究强调，有必要采取监管措施来加强农业实践，从而确保药用植物的安全性和有效性。

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来源期刊

Journal of pharmaceutical and biomedical analysis 医学-分析化学

CiteScore

6.70

自引率

5.90%

发文量

588

审稿时长

37 days

期刊介绍： This journal is an international medium directed towards the needs of academic, clinical, government and industrial analysis by publishing original research reports and critical reviews on pharmaceutical and biomedical analysis. It covers the interdisciplinary aspects of analysis in the pharmaceutical, biomedical and clinical sciences, including developments in analytical methodology, instrumentation, computation and interpretation. Submissions on novel applications focusing on drug purity and stability studies, pharmacokinetics, therapeutic monitoring, metabolic profiling; drug-related aspects of analytical biochemistry and forensic toxicology; quality assurance in the pharmaceutical industry are also welcome. Studies from areas of well established and poorly selective methods, such as UV-VIS spectrophotometry (including derivative and multi-wavelength measurements), basic electroanalytical (potentiometric, polarographic and voltammetric) methods, fluorimetry, flow-injection analysis, etc. are accepted for publication in exceptional cases only, if a unique and substantial advantage over presently known systems is demonstrated. The same applies to the assay of simple drug formulations by any kind of methods and the determination of drugs in biological samples based merely on spiked samples. Drug purity/stability studies should contain information on the structure elucidation of the impurities/degradants.