Soares José Cleberson Santos, Cavalcanti Iago Dillion Lima, Cruz-Filho Iranildo José da, Lira Nogueira Mariane Cajubá de Britto, Lima Maria do Carmo Alves de
Laboratório de Química e Inovação Terapêutica (LQIT), Universidade Federal de Pernambuco (UFPE), Recife 50670-901, Brazil.
Instituto Keizo-Asami (iLIKA), Universidade Federal de Pernambuco (UFPE), Recife 50670-901, Brazil.
ACS Omega. 2025 Apr 9;10(15):15697-15705. doi: 10.1021/acsomega.5c01148. eCollection 2025 Apr 22.
The validation of an analytical method enables the identification of the physicochemical characteristics of a molecule, aiding in the development of new drugs and allowing for its dosage in pharmaceutical forms. This is a crucial step in the creation of new pharmaceutical products. This article aims to validate a method for quantifying a novel indole-thiazole derivative with a -nitro substituent (CS03) encapsulated in nanoparticles. The CS03 quantification method was evaluated using HPLC-UV techniques based on selectivity, linearity, accuracy, precision, detection and quantification limits, and robustness. Additionally, the stability of CS03 in various simulated pH environments and its encapsulation in polysaccharide-coated nanoparticles were assessed. The method proved effective in quantifying CS03, demonstrating selectivity, linearity, precision, and accuracy, with detection and quantification limits appropriate for measuring the molecule postencapsulation in nanoparticles. The validated method is suitable for determining CS03, facilitating studies focused on the clinical application of this molecule for new drug development.
一种分析方法的验证能够确定分子的物理化学特性，有助于新药研发并确定其药物剂型的剂量。这是新型药品研发中的关键步骤。本文旨在验证一种用于定量包裹在纳米颗粒中的带有硝基取代基的新型吲哚-噻唑衍生物（CS03）的方法。基于选择性、线性、准确度、精密度、检测限和定量限以及稳健性，采用高效液相色谱-紫外技术对CS03定量方法进行了评估。此外，还评估了CS03在各种模拟pH环境中的稳定性及其在多糖包被纳米颗粒中的包封情况。该方法在定量CS03方面证明是有效的，具有选择性、线性、精密度和准确度，其检测限和定量限适合于测量纳米颗粒中包封后的该分子。经过验证的方法适用于测定CS03，有助于专注于该分子在新药研发临床应用方面的研究。
