An UPLC Method for Determination of Structural Analogues of DM1: the Payload of Trastuzumab Emtansine (T-DM1)

IF 1.3 4区化学 Q4 BIOCHEMICAL RESEARCH METHODS Chromatographia Pub Date : 2024-11-07 DOI:10.1007/s10337-024-04377-1

Junliang Yao, Yang Zhu, Daquan Yin

引用次数: 0

Abstract

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.

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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

DM1是美坦辛的衍生物，是曲妥珠单抗伊坦辛（T-DM1）的有效载荷。本文建立了一种新的梯度反相超高效色谱（RP-UPLC）方法，用于分析DM1的5种结构类似物（DM1-2、AP-3、DM1- 4d、DM1- 3d和DM1- 3l）。色谱分离采用Waters BEH Phenyl色谱柱（50 × 2.1 mm, 1.7 μm），波长252 nm。根据ICH指南对该方法进行特异性、准确性、精密度、线性和稳健性的验证。该方法简便、可靠，可用于DM1类似物杂质的定量测定。也可用于DM1散装样品中相关物质的测定。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Chromatographia 化学-分析化学

CiteScore

3.40

自引率

5.90%

发文量

103

审稿时长

2.2 months

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.