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首页> 外文期刊>Journal of Pharmaceutical Analysis >Evaluation of physicochemical properties as supporting information on quality control of raw materials and veterinary pharmaceutical formulations
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Evaluation of physicochemical properties as supporting information on quality control of raw materials and veterinary pharmaceutical formulations

机译：评估理化性质，作为原材料和兽药制剂质量控制的辅助信息

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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 C18(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.
机译：这项研究旨在表明，通过傅立叶变换红外光谱（FTIR），热重法（TG）和扫描电子显微镜（SEM）获得的理化特性可以用作评估活性药物成分（API）和药物产品质量的有用工具。此外，开发了一种使用HPLC-DAD的简单，灵敏，有效的方法，可同时测定原料和兽药制剂中的利多卡因（LID），环丙沙星（CFX）和恩诺沙星（EFX）。使用Gemini C18（250？mm×4.6？mm，5？μm）Phenomenex？色谱柱，在25°C的温度下，用含有10？mM磷酸（pH 3.29）的流动相：乙腈进行分离。 （85.7：14.3，v / v）和1.5？mL / min的流速。通过TG，FTIR和SEM对LID，CFX和EFX原料进行理化表征，为评估，区分和鉴定原料提供了有用的信息。最后，事实证明，HPLC方法除了可满足同时测定EFX，CFX和LID的分析方法的需求外，还可用于评估原材料和成品，该分析方法还可扩展至其他基质和应用。

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