Anacleto Sara da Silva, Borges Marcella Matos Cordeiro, de Oliveira Hanna Leijoto, Vicente Andressa Reis, de Figueiredo Eduardo Costa, de Oliveira Marcone Augusto Leal, Borges Bárbara Juliana Pinheiro, de Oliveira Marcelo Antonio, Borges Warley de Souza, Borges Keyller Bastos
Departamento de Ciências Naturais, Universidade Federal de São João del-Rei, Campus Dom Bosco, Praça Dom Helvécio 74, Fábricas, 36301-160 São João del-Rei, Minas Gerais, Brazil.
Departamento de Química, Universidade Federal do Espírito Santo, Avenida Fernando Ferrari, 514, Goiabeiras, 29075-910 Vitória, Espírito Santo, Brazil.
J Pharm Anal. 2018 Jun;8(3):168-175. doi: 10.1016/j.jpha.2018.01.001. Epub 2018 Jan 17.
This study aimed to show that the physicochemical proprieties obtained by Fourier transform infrared spectroscopy (FTIR), thermogravimetry (TG), and scanning electronic microscopy (SEM) can be useful tools for evaluating the quality of active pharmaceutical ingredients (APIs) and pharmaceutical products. In addition, a simple, sensitive, and efficient method employing HPLC-DAD was developed for simultaneous determination of lidocaine (LID), ciprofloxacin (CFX) and enrofloxacin (EFX) in raw materials and in veterinary pharmaceutical formulations. Compounds were separated using a Gemini C (250 mm × 4.6 mm, 5 µm) Phenomenex column, at a temperature of 25 °C, with a mobile phase containing 10 mM of phosphoric acid (pH 3.29): acetonitrile (85.7:14.3, v/v) and a flow rate of 1.5 mL/min. Physicochemical characterization by TG, FTIR, and SEM of raw materials of LID, CFX, and EFX provided information useful for the evaluation, differentiation, and qualification of raw materials. Finally, the HPLC method was proved to be useful for evaluation of raw material and finished products, besides satisfying the need for an analytical method that allows simultaneous determination of EFX, CFX, and LID, which can also be extended to other matrices and applications.
本研究旨在表明，通过傅里叶变换红外光谱（FTIR）、热重分析（TG）和扫描电子显微镜（SEM）获得的物理化学性质可作为评估活性药物成分（API）和药品质量的有用工具。此外，还开发了一种采用高效液相色谱-二极管阵列检测法（HPLC-DAD）的简单、灵敏且高效的方法，用于同时测定原料药和兽用药物制剂中的利多卡因（LID）、环丙沙星（CFX）和恩诺沙星（EFX）。使用Gemini C（250 mm×4.6 mm，5 µm） Phenomenex色谱柱在25°C的温度下分离化合物，流动相包含10 mM磷酸（pH 3.29）：乙腈（85.7:14.3，v/v），流速为1.5 mL/min。通过TG、FTIR和SEM对LID、CFX和EFX原料药进行的物理化学表征为原料的评估、鉴别和鉴定提供了有用信息。最后，事实证明HPLC方法除了满足同时测定EFX、CFX和LID的分析方法需求外，还可用于评估原料药和成品，并且该方法还可扩展到其他基质和应用。
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