利用液相色谱耦合 Orbitrap 质谱仪开发和验证胰高血糖素样肽-1 合成类似物艾塞那肽的稳定性指示检测方法和力降解产物的鉴定。

IF 1.1 4区 化学 Q4 PHYSICS, ATOMIC, MOLECULAR & CHEMICAL
European Journal of Mass Spectrometry Pub Date : 2024-06-01 Epub Date: 2024-07-26 DOI:10.1177/14690667241262935
Devendra Badgujar, Tejas Maskar, Sree Teja Paritala, Nitish Sharma
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引用次数: 0

摘要

艾塞那肽是一种合成的胰高血糖素样肽 1 类似物,广泛用于治疗 2 型糖尿病。医药产品的稳定性受到各种环境应力条件的严重影响。本研究采用 UHPLC-Orbitrap fusionTM 质谱仪开发了一种有效的反相高效液相色谱(RP-HPLC)稳定性指示方法,用于鉴定合成胰高血糖素样肽-1 类似物艾塞那肽的力降解产物(DPs)。将艾塞那肽置于水解、氧化、光解和热解等各种应力条件下进行了力降解研究,以考察该方法的稳定性指示能力。在酸性、氧化、光解和热应力条件下观察到了明显的降解。采用LC-HRMS和MS/MS方法对艾塞那肽及其主要DPs进行了鉴定和表征。通过MS/MS研究,共鉴定出五种主要的应激DPs,并提出了它们的碎片路径。最后,根据 ICH 指南对所提出的 RP-HPLC 方法进行了验证。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Development and validation of stability-indicating assay method and identification of force degradation products of glucagon-like peptide-1 synthetic analog Exenatide using liquid chromatography coupled with Orbitrap mass spectrometer.

Exenatide is a synthetic glucagon-like peptide 1 analog, widely used in the management of type 2 diabetes mellitus. The stability of pharmaceutical products is significantly impacted by various environmental stress conditions. The present study reports the development of a validated reverse-phase high-performance liquid chromatography (RP-HPLC) stability-indicating method for the identification of force degradation products (DPs) of synthetic glucagon-like peptide-1 analog Exenatide using UHPLC-Orbitrap fusionTM mass spectrometer. Force degradation studies were performed by subjecting Exenatide to various stress conditions, such as hydrolytic, oxidative, photolytic and thermal to investigate the stability indicating ability of the method. Significant degradation was observed during acidic, oxidative, photolytic and thermal stress conditions. Exenatide and its major DPs identification and characterization were demonstrated by employing LC-HRMS and MS/MS method. In total, five major stress DPs were characterized, and their fragmentation pathway was proposed using MS/MS studies. Finally, the proposed RP-HPLC method was validated as per ICH guidance.

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来源期刊
CiteScore
2.40
自引率
7.70%
发文量
16
审稿时长
>12 weeks
期刊介绍: JMS - European Journal of Mass Spectrometry, is a peer-reviewed journal, devoted to the publication of innovative research in mass spectrometry. Articles in the journal come from proteomics, metabolomics, petroleomics and other areas developing under the umbrella of the “omic revolution”.
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