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一种用于同时测定复方抗高血压药物比索洛尔和氨氯地平的绿色同步荧光分析方法。应用于血浆样品、市售制剂、含量均匀度测试及绿色度评价。

A Green Synchronous Fluorescence Analysis Approach for Simultaneous Determination of the Co-formulated Antihypertensives, Bisoprolol, and Amlodipine. Application to Plasma Samples, Market Formulations, Content Uniformity Test, and Greenness Evaluation.

作者信息

Kamel Gehad N, Shabana Rasha Abo, Hassan Ahmed H E, El-Shaheny Rania

机构信息

Department of Medicinal Chemistry, Faculty of Pharmacy, Mansoura University, Mansoura, Egypt.

Department of Pharmaceutical Analytical Chemistry, Faculty of Pharmacy, Mansoura University, Mansoura, Egypt.

出版信息

Luminescence. 2025 May;40(5):e70193. doi: 10.1002/bio.70193.

Abstract

In this study, we present a direct, sensitive, and green spectrofluorimetric approach for simultaneous measurement of bisoprolol fumarate (BSL) and amlodipine besylate (AMD) in their tablets and plasma. This approach measures the synchronized fluorescence intensity of the two drugs at Δλ of 55 nm with λ captured at 265 and 375 nm for BSL and AMD, respectively. The method is linear over the concentration range of 0.1-4.1 μg/mL for BSL and 1.0-9.0 μg/mL for AMD. The limit of detection for BSL and AMD is 0.0168 and 0.1227, and the limit of quantification is 0.0508 and 0.3717 μg/mL, respectively. This technique is effectively used to analyze the two studied drugs in their tablets with high %Recoveries of 100.09% for BSL and 99.67% for AMD and %RSD ≤ 1.54. The proposed technique is verified in compliance with the ICH Q2(R2) criteria. Hence, the suggested spectrofluorimetric approach effectively assesses the content uniformity of their tablets in accordance with the British Pharmacopoeia. Besides, BSL is determined in plasma over the range of 0.1-0.5 μg/mL with high percentage recoveries (98.95%-101.60%) and low %RSD values (1.326). The greenness of the developed method was positively assessed using three distinct green metrics, including AGREE, GAPI, and BAGI.

摘要

在本研究中,我们提出了一种直接、灵敏且绿色的荧光光谱法,用于同时测定富马酸比索洛尔(BSL)和苯磺酸氨氯地平(AMD)片剂及血浆中的含量。该方法通过测量两种药物在55nm波长差下的同步荧光强度,其中BSL和AMD的荧光波长分别为265nm和375nm。该方法在BSL浓度范围为0.1 - 4.1μg/mL、AMD浓度范围为1.0 - 9.0μg/mL时呈线性关系。BSL和AMD的检测限分别为0.0168和0.1227,定量限分别为0.0508和0.3717μg/mL。该技术有效地用于分析两种药物片剂,BSL和AMD的回收率分别高达100.09%和99.67%,相对标准偏差(%RSD)≤1.54。所提出的技术经验证符合ICH Q2(R2)标准。因此,所建议的荧光光谱法能有效地按照英国药典评估其片剂的含量均匀度。此外,在血浆中测定BSL的浓度范围为0.1 - 0.5μg/mL,回收率高(98.95% - 101.60%),%RSD值低(1.326)。使用三种不同的绿色指标(包括AGREE、GAPI和BAGI)对所开发方法的绿色度进行了积极评估。

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