{"title":"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","authors":"Ramesh Pawar, Sunil Tivari, Divya Panchani, Jayanti Makasana","doi":"10.1002/sscp.202400015","DOIUrl":null,"url":null,"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.","PeriodicalId":1,"journal":{"name":"Accounts of Chemical Research","volume":" February","pages":""},"PeriodicalIF":16.4000,"publicationDate":"2024-07-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":"{\"title\":\"A Stability‐Indicating RP‐HPLC Method for the Simultaneous Analysis of a Novel Synthetic Decapeptide and Six Related Substances\",\"authors\":\"Ramesh Pawar, Sunil Tivari, Divya Panchani, Jayanti Makasana\",\"doi\":\"10.1002/sscp.202400015\",\"DOIUrl\":null,\"url\":null,\"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.\",\"PeriodicalId\":1,\"journal\":{\"name\":\"Accounts of Chemical Research\",\"volume\":\" February\",\"pages\":\"\"},\"PeriodicalIF\":16.4000,\"publicationDate\":\"2024-07-19\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Accounts of Chemical Research\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.1002/sscp.202400015\",\"RegionNum\":1,\"RegionCategory\":\"化学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q1\",\"JCRName\":\"CHEMISTRY, MULTIDISCIPLINARY\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Accounts of Chemical Research","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1002/sscp.202400015","RegionNum":1,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"CHEMISTRY, MULTIDISCIPLINARY","Score":null,"Total":0}
A Stability‐Indicating RP‐HPLC Method for the Simultaneous Analysis of a Novel Synthetic Decapeptide and Six Related Substances
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.
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.