RGB Trichromatic Whiteness Assessment of Bio Analytical Chromatographic Tool Using Fluorescence for Quantitation of Semaglutide: Application to Pharmaceutical Preparations and Spiked Plasma.

IF 2.6 4区 化学 Q2 BIOCHEMICAL RESEARCH METHODS
Mona M Abdel Moneim, Miranda F Kamal, Mohamed M A Hamdy
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引用次数: 0

Abstract

Semaglutide (SEMG) is one of the most widely used and trending medications to treat type II diabetes and obesity. This work aimed to develop a liquid chromatography with spectroflourimetric detection (HPLC-flourimetry) analysis of SEMG in both its tablet dosage form and plasma. The power of fluorescence detection coupled with HPLC proved its capability as a bioanalytical tool to assay SEMG in plasma samples owing to its simplicity and sensitivity which reached below the Cmax of SEMG. Separation was done using a C18 column with mobile phase of acetonitrile and water acidified with orthophosphoric acid (pH 3.5) (1.41 × 10-5 M) in isocratic mode in ratio 57:43 and 1 mL/min flow rate after extraction using protein precipitation. Detection was carried out at λ excitation of 238 nm and λ emission of 416 and 307 nm for SEMG and the internal standard, respectively. Evaluation of greenness of the proposed method was done using AGREE (Analytical GREEnness Metric Approach), ComplexGAPI (Complementary Green Analytical Procedure Index) & the new algorithm RGB 12 model (Red-Green-Blue). They showed that these methods can be a greener alternative with acceptable sensitivity for analysis of SEMG. The developed seven min-assay was validated per ICH as well as FDA bio analytical methods' guidelines to prove its applicability for routine sample analysis and future pharmacokinetic studies.

利用荧光对用于塞马鲁肽定量的生物分析色谱工具进行 RGB 三基色白度评估:应用于药物制剂和加标血浆。
塞马鲁肽(SEMG)是治疗 II 型糖尿病和肥胖症最广泛使用和最流行的药物之一。这项研究旨在开发一种液相色谱-荧光检测法(HPLC-荧光检测法)分析 SEMG 的片剂和血浆。荧光检测法与高效液相色谱法的结合证明了其作为生物分析工具的能力,可以检测血浆样品中的 SEMG,因为它简单、灵敏,可以达到 SEMG 的 Cmax 以下。分离采用 C18 色谱柱,流动相为乙腈和用正磷酸(pH 3.5)(1.41 × 10-5 M)酸化的水(1.41 × 10-5 M),比例为 57:43,流速为 1 mL/min。SEMG 和内标物的 λ 激发波长为 238 nm,λ 发射波长分别为 416 nm 和 307 nm。使用 AGREE(分析绿色度量方法)、ComplexGAPI(互补绿色分析程序指数)和新算法 RGB 12 模型(红-绿-蓝)对拟议方法的绿色度进行了评估。他们的研究表明,这些方法可以成为 SEMG 分析的绿色替代方法,而且灵敏度可以接受。根据 ICH 和 FDA 生物分析方法指南,对所开发的七分钟测定方法进行了验证,以证明其适用于常规样品分析和未来的药代动力学研究。
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来源期刊
Journal of Fluorescence
Journal of Fluorescence 化学-分析化学
CiteScore
4.60
自引率
7.40%
发文量
203
审稿时长
5.4 months
期刊介绍: Journal of Fluorescence is an international forum for the publication of peer-reviewed original articles that advance the practice of this established spectroscopic technique. Topics covered include advances in theory/and or data analysis, studies of the photophysics of aromatic molecules, solvent, and environmental effects, development of stationary or time-resolved measurements, advances in fluorescence microscopy, imaging, photobleaching/recovery measurements, and/or phosphorescence for studies of cell biology, chemical biology and the advanced uses of fluorescence in flow cytometry/analysis, immunology, high throughput screening/drug discovery, DNA sequencing/arrays, genomics and proteomics. Typical applications might include studies of macromolecular dynamics and conformation, intracellular chemistry, and gene expression. The journal also publishes papers that describe the synthesis and characterization of new fluorophores, particularly those displaying unique sensitivities and/or optical properties. In addition to original articles, the Journal also publishes reviews, rapid communications, short communications, letters to the editor, topical news articles, and technical and design notes.
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