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用于在其氧化降解产物存在的情况下跨各种基质测定盐酸苄达明的两种离子选择性传感器的开发:绿色度、白度和蓝度评估。

Development of two ion-selective sensors for determining benzydamine hydrochloride in the presence of its oxidative degradant across various matrices: greenness, whiteness, and blueness appraisals.

作者信息

Kelani Khadiga M, Said Ragab A M, El-Dosoky Mohammad A, Abd El Halim Lobna M, Mohamed Ahmed R

机构信息

Pharmaceutical Analytical Chemistry Department, Faculty of Pharmacy, Cairo University, El‑Kasr El‑Aini Street, Cairo, 11562, Egypt.

Chemistry Department, Faculty of Pharmacy, Heliopolis University for Sustainable Development, Belbeis Desert Road, Cairo, Cairo, Egypt.

出版信息

BMC Chem. 2025 Sep 23;19(1):262. doi: 10.1186/s13065-025-01625-9.

DOI:10.1186/s13065-025-01625-9
PMID:40988049
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC12455838/
Abstract

Two sensitive and selective ion-selective electrodes (ISEs) were developed for the determination of benzydamine hydrochloride (BNZ·HCl): a conventional polyvinyl chloride (PVC) electrode and a coated graphite all solidstate ion-selective electrode (ASS-ISE). Both sensors were constructed using an ion-pair formed between BNZ⁺ and the lipophilic anion tetraphenylborate (TPB⁻), incorporated into the sensing membranes. The sensors exhibited near-Nernstian responses with slopes of 58.09 And 57.88 mV/decade, over a Linear range of 10-10 M, and detection Limits of 5.81 × 10M and 7.41 × 10 M, respectively. They demonstrated high accuracy and precision for the determination of BNZ·HCl in pure form, pharmaceutical cream, and biological fluids, with no matrix interference. The method also proved stability-indicating, successfully detecting BNZ·HCl in the presence of its oxidative degradant. Validation was performed according to ICH guidelines, and the method showed strong environmental compatibility based on greenness, whiteness, and blueness assessments, supporting its suitability for sustainable pharmaceutical analysis.

摘要

开发了两种用于测定盐酸苄达明(BNZ·HCl)的灵敏且选择性高的离子选择性电极(ISE):一种是传统的聚氯乙烯(PVC)电极,另一种是涂覆石墨全固态离子选择性电极(ASS - ISE)。两种传感器均通过将BNZ⁺与亲脂性阴离子四苯基硼酸根(TPB⁻)形成的离子对掺入传感膜中构建而成。这些传感器在10⁻¹⁰ M的线性范围内呈现近能斯特响应,斜率分别为58.09和57.88 mV/十倍浓度变化,检测限分别为5.81×10⁻¹¹ M和7.41×10⁻¹¹ M。它们在测定纯形式、药用乳膏和生物流体中的BNZ·HCl时显示出高精度和精密度,无基质干扰。该方法还证明具有稳定性指示性,能在其氧化降解产物存在的情况下成功检测到BNZ·HCl。根据国际协调会议(ICH)指南进行了验证,并且基于绿色度、白度和蓝度评估,该方法显示出很强的环境兼容性,支持其适用于可持续药物分析。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e3e/12455838/b8110d6e93e2/13065_2025_1625_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e3e/12455838/45dfa56e62c0/13065_2025_1625_Fig1_HTML.jpg
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https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e3e/12455838/6e5f31de3d2d/13065_2025_1625_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e3e/12455838/0fd3aa02ad64/13065_2025_1625_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e3e/12455838/d7ddd5e96cd7/13065_2025_1625_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e3e/12455838/b8110d6e93e2/13065_2025_1625_Fig6_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e3e/12455838/45dfa56e62c0/13065_2025_1625_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e3e/12455838/d3095c2f5ea5/13065_2025_1625_Fig2_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e3e/12455838/6e5f31de3d2d/13065_2025_1625_Fig3_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e3e/12455838/0fd3aa02ad64/13065_2025_1625_Fig4_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e3e/12455838/d7ddd5e96cd7/13065_2025_1625_Fig5_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/5e3e/12455838/b8110d6e93e2/13065_2025_1625_Fig6_HTML.jpg

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