能量色散x射线荧光技术(EDXRF)分析方法在制药科学中的应用验证

T. Paulino, J. O. Oliveira Júnior, D. Baldo, N. Aranha, D. B. Gonçalves, M. M. D. C. Vila, V. Balcão
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引用次数: 1

摘要

用于生产药品的原料中杂质的测定对于保证最终产品的质量以及避免对健康造成损害至关重要。金属杂质即使在低浓度下也会表现出毒性作用,因此允许的水平由监管机构和药典规定。然而,在巴西官方的药典中很少有方法。从这个意义上说,必须评估快速、敏感和精确的技术,如能量色散x射线荧光技术(EDXRF),以分析药用材料中的金属。因此,这样就有必要调查污染物的存在及其浓度水平。本研究工作的主要目的是验证一种使用能量色散x射线荧光(EDXRF)技术识别和量化原料和药品化学成分的方法。所使用的方法是基于微晶纤维素基质的选择,该基质中添加了ICH指南Q3D定义的两类污染物元素,1类(Cd, Pb, As, Hg)和2A类(Co, V, Ni)。采用EDXRF技术进行定性和定量分析,结果证明该技术非常有效,符合强制性官方药典(巴西卫生监管机构(Anvisa) nº166,2017年7月24日)要求的所有验证参数,如选择性、线性、精密度、检出限、定量限和鲁棒性。本研究表明,EDXRF可以作为1类和2A类元素杂质的检测和定量技术。
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Validation of the analytical method using the energy dispersive X-ray fluorescence technique (EDXRF) for application in pharmaceutical sciences
The determination of impurities in raw materials intended for the production of pharmaceutical products is important to guarantee the quality of the final product, as well as to avoid damage to health. Metallic impurities can exhibit toxic effects even at low concentrations and so permissible levels are defined by the regulatory agencies and pharmacopeias. However, few methods are presented in official compendia in Brazil. In this sense, fast, sensitive, and precise techniques such as the energy dispersive X-ray fluorescence technique (EDXRF) must be evaluated for the analysis of metals in materials for pharmaceutical use. This way, therefore, there is the need to investigate the presence of contaminants and their concentration levels. The major goal of this research work was to validate a method for using the Energy Dispersive X-Ray Fluorescence (EDXRF) technique to identify and quantify the chemical composition of raw materials and pharmaceutical products. The methodology used was based on the selection of a microcrystalline cellulose matrix, which was spiked with two classes of contaminant elements, Class 1 (Cd, Pb, As, Hg) and Class 2A (Co, V, Ni) as defined by ICH guideline Q3D. The qualitative and quantitative analyses were carried out using the EDXRF technique, which proved to be quite effective and met all the validation parameters required in the mandatory official compendia (Resolution of the Collegiate Board (RDC) of Brazilian Health Regulatory Agency (Anvisa) nº 166, July 24, 2017), such as selectivity, linearity, precision, detection limit, quantification limit and robustness. This study showed that EDXRF can be used as a technique for detection and quantification of elemental impurities belonging to Class 1 and Class 2A.
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