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The evaluation of alternative method of ferrous ions assessment in pharmaceutical preparations

机译:药物制剂中铁离子评估替代方法评价

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摘要

The atomic absorption spectrometry (AAS) method is one of the most accessible procedures for ferrous ions testing in various compositions including pharmaceutical preparations. The aim of the study was to develop and partially validate analytical method which could be an excellent alternative to the routine procedure performed within dissolution studies. Electric conductivity is simple, fast, and hassle-free method. The samples during dissolution process were measured using conductivity probe in entire dissolution assessment protocol. The conductivity results were compared to data obtained from AAS. The dissolution studies were performed according to modified pharmacopoeial standards, in 900?cm_(3)of purified water as an acceptor medium, at 37?°C, until the achievement of an equilibrium state for every tested composition. Validity study of the developed method confirmed acceptable linearity of obtained calibration plots ( r _(2)?>?0.9553). Linearity at 100% level was found to be 100.59, 97.49, and 94.82, respectively, for drug compositions A, B, and C. Precision results were 100.45, 95.97, and 95.73, respectively, for A, B, and C, with RSD below 2% between all samples in all above mentioned formulations. The drug composition D hindered the proper validation of the method due to the high variability between samples. The method has acceptable performance features for evaluation of three of four solid drug composition containing ferrous ions. Graphical abstract.
机译:原子吸收光谱法(AAS)方法是在包括药物制剂的各种组合物中的铁离子测试中最可达的方法之一。该研究的目的是开发和部分地验证分析方法,这可能是对溶解研究中的常规程序的优异替代方案。电导率简单,快速,无忧无虑的方法。在整个溶解评估方案中使用导电探针测量溶解过程中的样品。将导电率结果与AAS获得的数据进行比较。根据修饰的药物发作标准品,在900℃的纯化水中作为受体培养基,在37Ω·℃下进行溶出性研究,直至每种测试组合物的平衡状态。开发方法的有效性研究证实了获得的校准图的可接受线性(R _(2)?>?0.9553)。发现100%水平的线性分别为100.59,97.49和94.82,用于药物组合物A,B和C.精确的结果分别为100.45,95.97和95.73,用于A,B和C,具有RSD在所有上述制剂中的所有样品之间低于2%。药物组合物D由于样品之间的高可变性阻碍了该方法的适当验证。该方法具有可接受的性能特征,用于评估含有含铁离子的四种固体药物组合物中的三种。图形概要。

著录项

  • 来源
    《Monatshefte fur Chemie 》 |2018年第5期| 共7页
  • 作者单位

    Pharmaceutical Faculty Department of Physical Chemistry Wroclaw Medical University;

    Pharmaceutical Faculty Department of Bromatology and Dietetics Wroclaw Medical University;

    Pharmaceutical Faculty Department of Pharmacology Ankara University;

    Pharmaceutical Faculty Department of Bromatology and Dietetics Wroclaw Medical University;

    Pharmaceutical Faculty Department of Physical Chemistry Wroclaw Medical University;

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  • 原文格式 PDF
  • 正文语种 eng
  • 中图分类 化学 ;
  • 关键词

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