{"title":"一种测定DM1结构类似物的UPLC方法：曲妥珠单抗Emtansine （T-DM1）的有效负荷","authors":"Junliang Yao, Yang Zhu, Daquan Yin","doi":"10.1007/s10337-024-04377-1","DOIUrl":null,"url":null,"abstract":"<div><p>DM1, a derivative of maytansine, is the payload of trastuzumab emtansine (T-DM1). In this work, a new gradient reverse-phase ultra-performance chromatographic (RP-UPLC) method was proposed for analysis of five structural analogues (DM1-2, AP-3, DM1-4D, DM1-3D, and DM1-3L) of DM1. The chromatographic separation was accomplished by using a Waters BEH Phenyl column (50 × 2.1 mm, 1.7 μm), at the wavelength of 252 nm. Validation of the method was carried out according the ICH guidelines in terms of specificity, accuracy, precision, linearity and robustness. The developed method was proved to be convenient and reliable for quantitative determination of the DM1 analogue impurities. It can also be used for the related substances determination in DM1 bulk samples.</p></div>","PeriodicalId":518,"journal":{"name":"Chromatographia","volume":"88 1","pages":"11 - 18"},"PeriodicalIF":1.3000,"publicationDate":"2024-11-07","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://link.springer.com/content/pdf/10.1007/s10337-024-04377-1.pdf","citationCount":"0","resultStr":"{\"title\":\"An UPLC Method for Determination of Structural Analogues of DM1: the Payload of Trastuzumab Emtansine (T-DM1)\",\"authors\":\"Junliang Yao, Yang Zhu, Daquan Yin\",\"doi\":\"10.1007/s10337-024-04377-1\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<div><p>DM1, a derivative of maytansine, is the payload of trastuzumab emtansine (T-DM1). In this work, a new gradient reverse-phase ultra-performance chromatographic (RP-UPLC) method was proposed for analysis of five structural analogues (DM1-2, AP-3, DM1-4D, DM1-3D, and DM1-3L) of DM1. The chromatographic separation was accomplished by using a Waters BEH Phenyl column (50 × 2.1 mm, 1.7 μm), at the wavelength of 252 nm. Validation of the method was carried out according the ICH guidelines in terms of specificity, accuracy, precision, linearity and robustness. The developed method was proved to be convenient and reliable for quantitative determination of the DM1 analogue impurities. It can also be used for the related substances determination in DM1 bulk samples.</p></div>\",\"PeriodicalId\":518,\"journal\":{\"name\":\"Chromatographia\",\"volume\":\"88 1\",\"pages\":\"11 - 18\"},\"PeriodicalIF\":1.3000,\"publicationDate\":\"2024-11-07\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://link.springer.com/content/pdf/10.1007/s10337-024-04377-1.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Chromatographia\",\"FirstCategoryId\":\"92\",\"ListUrlMain\":\"https://link.springer.com/article/10.1007/s10337-024-04377-1\",\"RegionNum\":4,\"RegionCategory\":\"化学\",\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"BIOCHEMICAL RESEARCH METHODS\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Chromatographia","FirstCategoryId":"92","ListUrlMain":"https://link.springer.com/article/10.1007/s10337-024-04377-1","RegionNum":4,"RegionCategory":"化学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"BIOCHEMICAL RESEARCH METHODS","Score":null,"Total":0}
An UPLC Method for Determination of Structural Analogues of DM1: the Payload of Trastuzumab Emtansine (T-DM1)
DM1, a derivative of maytansine, is the payload of trastuzumab emtansine (T-DM1). In this work, a new gradient reverse-phase ultra-performance chromatographic (RP-UPLC) method was proposed for analysis of five structural analogues (DM1-2, AP-3, DM1-4D, DM1-3D, and DM1-3L) of DM1. The chromatographic separation was accomplished by using a Waters BEH Phenyl column (50 × 2.1 mm, 1.7 μm), at the wavelength of 252 nm. Validation of the method was carried out according the ICH guidelines in terms of specificity, accuracy, precision, linearity and robustness. The developed method was proved to be convenient and reliable for quantitative determination of the DM1 analogue impurities. It can also be used for the related substances determination in DM1 bulk samples.
期刊介绍：
Separation sciences, in all their various forms such as chromatography, field-flow fractionation, and electrophoresis, provide some of the most powerful techniques in analytical chemistry and are applied within a number of important application areas, including archaeology, biotechnology, clinical, environmental, food, medical, petroleum, pharmaceutical, polymer and biopolymer research. Beyond serving analytical purposes, separation techniques are also used for preparative and process-scale applications. The scope and power of separation sciences is significantly extended by combination with spectroscopic detection methods (e.g., laser-based approaches, nuclear-magnetic resonance, Raman, chemiluminescence) and particularly, mass spectrometry, to create hyphenated techniques. In addition to exciting new developments in chromatography, such as ultra high-pressure systems, multidimensional separations, and high-temperature approaches, there have also been great advances in hybrid methods combining chromatography and electro-based separations, especially on the micro- and nanoscale. Integrated biological procedures (e.g., enzymatic, immunological, receptor-based assays) can also be part of the overall analytical process.
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