用于测定某些新型化疗药物制剂的一步法绿色微孔分光光度法。

Ibrahim A Darwish, Hany W Darwish, Mohammed S Alsalhi
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引用次数: 0

摘要

背景:碘与五种用于治疗不同类型癌症的化疗药物形成电荷转移复合物(CTCs)的情况尚未得到研究。这些药物是奥拉帕利(olaparib)、赛力克(seliciclib)、凡德他尼(vandetanib)、达沙替尼(dasatinib)和托唑替尼(tozasertib)。此外,无论这些药物的化学结构有何不同,都需要一种适当的通用分光光度测定法来分析其剂型:本研究的目的是开发一种新型微孔分光光度测定法(MW-SPA),通过碘与这些药物的共反应,在瞬间产生明亮的柠檬黄色四氯化碳,从而一步测定这些药物:对四氯化碳进行了分光光度法研究,并对所有四氯化碳进行了特征描述。方法:对四氯化碳进行了分光研究,并对所有四氯化碳进行了表征,确定了每种药物的相互作用位点,开发了 MW-SPA 并将其应用于剂型分析:结果:研究结果证实,反应是通过形成四氯化碳进行的。在 1-6 µg/mL 的一般浓度范围内,均符合比尔定律。检测限和定量限分别为 0.5-2.1 微克/毫升和 1.5-6.4 微克/毫升。拟议的 MW-SPA 具有极佳的精密度,测定内精密度和测定间精密度的相对标准偏差分别小于 2.24% 和 2.23%。回收率研究证明了 MW-SPA 的准确性。使用 MW-SPA 成功地测定了所有散装和片剂药物。确定了所建议方法的环境可持续性,从而证明该检测方法符合绿色分析化学的基础。结论:结论:与其他现有方法相比,本文所述的 MW-SPA 可以在相同波长下分析所有药物:亮点:该测定法适用于质量控制实验室对药物制剂进行常规分析。
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A One-Step Green Microwell Spectrophotometric Assay for the Determination of Certain New Chemotherapeutic Drug Formulations.

Background: The formation of charge-transfer complexes (CTCs) of iodine with five chemotherapeutic drugs used for the treatment of different types of cancer has not been investigated. These drugs are olaparib, seliciclib, vandetanib, dasatinib, and tozasertib. Additionally, these drugs need an appropriate general spectrophotometric assay for their analysis in the dosage forms regardless of the differences in their chemical structures.

Objective: The aim of this study was the development of a novel microwell spectrophotometric assay (MW-SPA) for one-step determination of these drugs via their interactions with iodine, which resulted in instantaneous production of bright lemon-yellow CTCs.

Methods: A spectrophotometric study of the CTCs was conducted, and all CTCs were characterized. Site(s) of interaction on each drug were assigned, and the MW-SPA was developed and applied to the analysis of dosage forms.

Results: The findings confirmed that the reactions proceeded via CTC formation. Beer's law was obeyed over a general concentration range of 1-6 µg/mL. The LODs and LOQs were in the ranges of 0.5-2.1 and 1.5-6.4 µg/mL, respectively. The proposed MW-SPA demonstrated excellent precisions as the relative standard deviations were < 2.24 and 2.23% for the intra- and inter-assay precision, respectively. Recovery studies demonstrated the accuracy of MW-SPA. Successful determination of all drugs in bulk and tablet forms was achieved using the MW-SPA. The environmental sustainability of the proposed methodology was determined, providing evidence of the assay's alignment with the basis of green analytical chemistry. The high throughput of the assay was documented.

Conclusion: In contrast to other existing methods, the MW-SPA described herein was valid for analyzing all drugs at the same wavelength.

Highlights: The assay is useful for routine analysis of drugs in their formulations in QC laboratories.

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