背景:瑞波西汀(RBX)是FDA批准的第一种选择性去甲肾上腺素再摄取抑制剂类的抗抑郁药。严重需要一种用于定量其剂型中的RBX的方便的分析工具。
目的:本研究旨在开发和验证用于RBX药物分析的两个绿色和高通量微孔光谱平台。
方法:两个平台,缩写为MW-AB和MW-FL,涉及基于微孔的分析,辅助多功能微孔板读数器测量吸光度和荧光信号,分别。MW-AB和MW-FL平台涉及RBX与氧化邻苯二酚试剂(OPC)和四氰基喹二甲烷(TCNQ)反应后形成有色和荧光衍生物,分别。有色RBX-OPC衍生物在520nm处的吸光度,RBX-TCNQ电荷转移复合物在283nm和484nm处的荧光用于激发和发射,分别。建立了两个反应的最佳条件,确定了它们的摩尔比,并推测了反应机制。
结果:根据国际协调理事会的指南对这两个平台进行了优化和验证。MW-AB和MW-FL的定量限为19.6µg/mL和27ng/mL,分别。两种平台均以优异的可靠性应用于Edranox®片剂中RBX含量的定量及其药物均匀性。两个平台的绿色水平由两个综合工具评估,结果证实了两个平台的绿色水平。
结论:两个平台都涉及一步反应,适应的微孔分析,同时处理大量样品。因此,它们具有绿色和高通量分析的优点。
结论:提出的两个平台是快速定量RBX的有价值的工具。
BACKGROUND: Reboxetine (RBX) is the first FDA-approved antidepressant drug of the selective noradrenaline reuptake inhibitors class. There is a serious need for a convenient analytical tool for the quantitation of RBX in its dosage form.
OBJECTIVE: This study aims to the development and validation of two green and high throughput microwell spectrometric platforms for the pharmaceutical analysis of RBX.
METHODS: The two platforms, abbreviated as MW-AB and MW-FL, involved microwell-based analysis assisted with a multifunction microplate plate reader for measuring absorbance and fluorescence signals, respectively. The MW-AB and MW-FL platforms involved the formation of colored and fluorescent derivatives upon the reaction of RBX with oxidized pyrocatechol reagent (OPC) and tetracyanoquinodimethane (TCNQ), respectively. The absorbance of colored RBX-OPC derivative at 520 nm, and the fluorescence of RBX-TCNQ charge transfer complex at 283 nm and 484 nm for excitation and emission, respectively. The optimum conditions of both reactions were established, their molar ratios were determined, and reaction mechanisms were postulated.
RESULTS: Both platforms were optimized and validated according to the guidelines of the International Council on Harmonization. The limits of quantitation were 19.6 µg/mL and 27 ng/mL for MW-AB and MW-FL, respectively. Both platforms were applied with excellent reliability to the quantitation of RBX content in Edranox® tablets and their drug uniformity. The greenness levels of both platforms were assessed by two comprehensive tools, and the results confirmed the high level of greenness for both platforms.
CONCLUSIONS: Both platforms involved one-step reactions, adapted microwell analysis, and simultaneous handling of large number of samples. Therefore, they have the advantages of greenness and high throughput analysis.
CONCLUSIONS: The proposed two platforms are valuable tools for the rapid quantitation of RBX.