![Author ORCID: We display the ORCID iD icon alongside authors names on our website to acknowledge that the ORCiD has been authenticated when entered by the user. To view the users ORCiD record click the icon. [opens in a new tab]](https://www.cambridge.org/engage/assets/public/coe/logo/orcid.png){kind=logo}
Abstract
Neratinib is a tyrosine kinase inhibitor prescribed for the treatment of breast cancer. The key step for the synthesis of neratinib involves the coupling of 4-N,N-dimethylaminocrotonic acid with 6-amino-4-[3-chloro-4-(2-pyridinyl methoxy)-anilino]-3-cyano-7-ethoxy quinolone. Several potential process related impurities are formed during the synthesis, including unreacted starting materials, and degradation products. These impurities are monitored by high-performance liquid chromatography (HPLC) and mass spectrometry (MS) to ensure the purity and quality of the final product. This study highlights the synthesis of neratinib impurity-H, and its detection by a new HPLC method. The HPLC method employed a C18 column (150 x 4.6 mm, 5μm) with a gradient flow of 1 ml min-1 of ethanol and phosphate buffer (pH 3.40) as a green solvent. The AGREE score confirmed the environmental benefits of using ethanol in the development of the liquid chromatographic method.
