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

IF 1.7 4区 化学 Q3 CHEMISTRY, MULTIDISCIPLINARY Monatshefte Fur Chemie Pub Date : 2018-01-01 Epub Date: 2018-02-13 DOI:10.1007/s00706-018-2147-5
Anna Lisik, Anna Prescha, Levent E Cavlaz, Halina Grajeta, Witold Musiał
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引用次数: 1

Abstract

Abstract: 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 cm3 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 (r2 > 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.

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药物制剂中亚铁离子评价替代方法的评价。
摘要:原子吸收光谱法(AAS)是测定包括药物制剂在内的各种组合物中亚铁离子最简便易行的方法之一。本研究的目的是开发和部分验证分析方法,该方法可能是溶出度研究中常规程序的一个很好的替代方法。电导率法简单、快速、省事。在整个溶出评估方案中,采用电导率探针测量溶出过程中的样品。电导率结果与原子吸收光谱测定结果进行了比较。根据修改的药典标准进行溶出研究,在900 cm3纯净水中作为受体介质,在37°C下,直到每个被测组合物达到平衡状态。方法的效度研究证实,得到的标定图线性度可接受(r2 > 0.9553)。A、B、C在100%水平上的线性分别为100.59、97.49、94.82,A、B、C的精密度分别为100.45、95.97、95.73,RSD均小于2%。由于样品之间的高度可变性,药物组合物D阻碍了该方法的适当验证。该方法具有可接受的性能特征,用于评价含有亚铁离子的四种固体药物组合物中的三种。图形化的简介:
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来源期刊
Monatshefte Fur Chemie
Monatshefte Fur Chemie 化学-化学综合
CiteScore
3.70
自引率
5.60%
发文量
116
审稿时长
3.3 months
期刊介绍: "Monatshefte für Chemie/Chemical Monthly" was originally conceived as an Austrian journal of chemistry. It has evolved into an international journal covering all branches of chemistry. Featuring the most recent advances in research in analytical chemistry, biochemistry, inorganic, medicinal, organic, physical, structural, and theoretical chemistry, Chemical Monthly publishes refereed original papers and a section entitled "Short Communications". Reviews, symposia in print, and issues devoted to special fields will also be considered.
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