Anastasiia Belikova, Anna Materienko, L. Sidorenko, V. Chornyi, I. Korzh, Luidmula Kucherenko, A. Kotvitska, Deividas Burdulis, V. Georgiyants
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引用次数: 0
摘要
药物开发的主要步骤之一是质量控制方法的选择。方法的正确性必须通过验证来确认。此外,制造商还要考虑各种经济和环境因素。对于国内和有发展前景的药物,如噻唑酸morpholinium,上述方面的确定尤为重要。的目标。在制定药品常规分析方法的过程中,应注意分析的效率、预算以及对环境的影响。由于这个原因,不仅要开发新的常规分析方法。重要的是,这种方法必须对环境友好,成本效益高。材料和方法。采用SunFire C18 (150 mm × 4,6 mm, 5,0 μm)高效液相色谱(HPLC)和Rxi-5 ms(长30 m,外径0.25 mm,液固定相厚度0.25 μm)火焰电离检测器,气相色谱法测定噻唑酸morpholinium。建立了噻唑酸铵常规定量分析的多种色谱方法。确定了样品制备的最佳条件。对提出的方法进行比较,找出最生态和最经济的方法。所提方法准确可靠。然而,一项环境影响评估表明,GC-FID是一种更环保、更经济的分析方法。利用绿色分析化学的12个原则,计算出所建议的分析方法的总体“分析绿色度(AGREE)”尺度为0.72,表明所建议的分析方法具有良好的绿色性质
Development of a method for determining the morpholinium thiazotate using more economic and green GC/MS assay with an fid detector
One of the main steps in the pharmaceutical development of drugs is the choice of quality control methods. The correctness of the method must be confirmed by validation. In addition, manufacturers take into account various economic and environmental factors. It is especially important to determine the above aspects for domestic and promising drugs, such as the morpholinium thiazotate.
The aim. During the development of methods for the routine analysis of medicinal products, attention should be paid to efficiency of analysis, budget, as well as their impact to the environment. Because of this reason, not only new methods for routine analysis should be developed. It is important this methods must be environmentally-friendly and cost-efficient.
Materials and methods. The determination of the morpholinium thiazotate was carried out by HPLC using the SunFire C18 (150 mm × 4,6 mm, 5,0 μm) and gas chromatography with a flame ionization detector using the Rxi-5 ms (30 m long, 0.25 mm outer diameter and 0.25 μm liquid stationary phase thickness).
Results. Various chromatographic methods for the routine quantitative analysis of morpholinium thiazotate were developed. The most suitable conditions for sample preparation were established. Proposed methods were compared to find the most ecological and economic.
Conclusions. Proposed methods were accurate and reliable. However, an environmental impact assessment showed that GC-FID is a more environmentally friendly and economical method of analysis. Using 12 Principles of green analytical chemistry, the overall “analytical GREEnness (AGREE)” scale for the proposed analytical approach was computed 0.72, showing the good greener nature of the proposed analytical approach