A Stability‐Indicating RP‐HPLC Method for the Simultaneous Analysis of a Novel Synthetic Decapeptide and Six Related Substances

IF 17.7 1区化学 Q1 CHEMISTRY, MULTIDISCIPLINARY Accounts of Chemical Research Pub Date : 2024-07-19 DOI:10.1002/sscp.202400015

Ramesh Pawar, Sunil Tivari, Divya Panchani, Jayanti Makasana

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Abstract

Currently, the therapeutic potential of complex biomolecules such as peptides has significantly enhanced the demand for analytical method development and validation for their quality control. Peptides are more complex to analyze than small molecules because of their larger size and unique physical–chemical properties, which create different challenges for analytical method development. Reversed‐phase high‐performance liquid chromatography (RP‐HPLC) with ultraviolet or mass spectrometry is the most widely used technique for analyzing peptides and related substances. In the present study, a decapeptide and its six related possible impurities were synthesized in‐house and identified. A stability‐indicating RP‐HPLC method has been developed for the estimation of the decapeptide and its related substances. The developed method was validated according to the International Conference on Harmonization guidelines for specificity, linearity, limit of detection, quantification, accuracy, precision, and robustness. The stability‐indicating capability of the proposed method was studied under the stress conditions of acid, base, oxidative, thermal, humidity, and photolytic degradation. The decapeptide peak and its degradant were found to be homogeneous and pure in the studied stress trials, with mass balance for all types of degradation exceeding 95%. It confirms the reliability and appropriateness of determining the integrity and purity of the decapeptide and its related substances.

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一种同时分析新型合成十肽和六种相关物质的稳定指示型 RP-HPLC 方法

目前，多肽等复杂生物大分子的治疗潜力大大提高了对其质量控制的分析方法开发和验证的需求。与小分子相比，多肽的分析更为复杂，因为它们具有较大的体积和独特的物理化学性质，这给分析方法的开发带来了不同的挑战。反相高效液相色谱法（RP-HPLC）结合紫外光谱或质谱法是分析多肽及相关物质最广泛使用的技术。本研究在内部合成并鉴定了一种十肽及其六种可能的相关杂质。为估算十肽及其相关物质，建立了一种稳定性指示的 RP-HPLC 方法。所开发的方法在特异性、线性、检出限、定量、准确度、精密度和稳健性等方面均符合国际协调准则。研究了该方法在酸、碱、氧化、热、湿度和光降解等应激条件下的稳定性。结果表明，在所研究的应力试验中，十肽峰及其降解物均是均匀纯净的，所有降解类型的质量平衡均超过 95%。这证实了测定十肽及其相关物质的完整性和纯度的可靠性和适当性。

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来源期刊

Accounts of Chemical Research 化学-化学综合

CiteScore

31.40

自引率

1.10%

发文量

312

审稿时长

2 months

期刊介绍： Accounts of Chemical Research presents short, concise and critical articles offering easy-to-read overviews of basic research and applications in all areas of chemistry and biochemistry. These short reviews focus on research from the author’s own laboratory and are designed to teach the reader about a research project. In addition, Accounts of Chemical Research publishes commentaries that give an informed opinion on a current research problem. Special Issues online are devoted to a single topic of unusual activity and significance. Accounts of Chemical Research replaces the traditional article abstract with an article "Conspectus." These entries synopsize the research affording the reader a closer look at the content and significance of an article. Through this provision of a more detailed description of the article contents, the Conspectus enhances the article's discoverability by search engines and the exposure for the research.