Towards greener pharmaceutical quality control: first green UV-based analytical strategies for assaying the newly-introduced candesartan/chlorthalidone mixture in their pharmaceutical and dissolution medium

IF 5.8 2区 化学 Q2 CHEMISTRY, MULTIDISCIPLINARY
Ahmed R. Mohamed , Eman Darweish , Sara El-Hanboushy
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Abstract

Emerging evidence suggests that antihypertensive therapies, particularly angiotensin II receptor blockers, play a crucial role in reinforcing clinical outcomes and hastening recovery in COVID-19 patients with hypertension. Thus, this study introduces the first UV scenarios for concurrent analysis of candesartan cilexetil (CDS) and chlorthalidone (CTL), which have superimposed UV spectra. The UV scenarios were the dual-wavelength (DUW) method and the Fourier deconvoluted (FOD) method. These scenarios were successfully implemented for the examination of CDS and CTL in their crude and commercial forms. In addition, this study provided a dissolution study of their formulation in accordance with the FDA's guidelines. The linear ranges were established to be (1.0–40.0) μg/mL for CDS and (5.0–60.0) μg/mL for CTL. The LOD values ranged between (0.23–0.24) μg/mL and (0.74–0.75) μg/mL for CDS and CTL, in order. Validation and confirmation of the proposed scenarios were performed according to ICH guidelines, yielding satisfactory results within acceptable limits. Statistical appraisal with the published platform revealed no significant differences. Aligned with green analytical chemistry principles, the proposed scenarios were appraised for their environmental impact and contrasted to the published platform using Eco-Scale and AGREEprep tools. The favorable results, coupled with the methods' sustainability, affordability, simplicity, and high sensitivity, support their use in routine QC testing.

Abstract Image

迈向更绿色的药品质量控制:第一个基于绿色紫外的分析策略,用于分析新引入的坎地沙坦/氯噻酮混合物在其药物和溶解介质中的含量
新出现的证据表明,抗高血压治疗,特别是血管紧张素II受体阻滞剂,在加强COVID-19高血压患者的临床结果和加速康复方面发挥着至关重要的作用。因此,本研究首次引入了坎地沙坦西莱西酯(CDS)和氯噻酮(CTL)的紫外光谱叠加分析。紫外场景为双波长(DUW)法和傅立叶反卷积(FOD)法。这些方案已成功地用于检查CDS和CTL的原始和商业形式。此外,本研究还根据FDA的指导方针对其制剂进行了溶出度研究。CDS和CTL的线性范围分别为(1.0 ~ 40.0)和(5.0 ~ 60.0)μg/mL。CDS和CTL的LOD值依次为(0.23 ~ 0.24)μg/mL和(0.74 ~ 0.75)μg/mL。根据ICH指南对提议的方案进行验证和确认,在可接受的范围内产生满意的结果。与已发布的平台进行统计评估显示无显著差异。根据绿色分析化学原则,我们评估了建议方案的环境影响,并使用Eco-Scale和AGREEprep工具与已发布的平台进行了对比。良好的结果,加上该方法的可持续性、可负担性、简单性和高灵敏度,支持其在常规QC检测中的应用。
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来源期刊
Sustainable Chemistry and Pharmacy
Sustainable Chemistry and Pharmacy Environmental Science-Pollution
CiteScore
8.20
自引率
6.70%
发文量
274
审稿时长
37 days
期刊介绍: Sustainable Chemistry and Pharmacy publishes research that is related to chemistry, pharmacy and sustainability science in a forward oriented manner. It provides a unique forum for the publication of innovative research on the intersection and overlap of chemistry and pharmacy on the one hand and sustainability on the other hand. This includes contributions related to increasing sustainability of chemistry and pharmaceutical science and industries itself as well as their products in relation to the contribution of these to sustainability itself. As an interdisciplinary and transdisciplinary journal it addresses all sustainability related issues along the life cycle of chemical and pharmaceutical products form resource related topics until the end of life of products. This includes not only natural science based approaches and issues but also from humanities, social science and economics as far as they are dealing with sustainability related to chemistry and pharmacy. Sustainable Chemistry and Pharmacy aims at bridging between disciplines as well as developing and developed countries.
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