Development of novel green and high-throughput microwell spectrophotometric assay for one-step determination of dacomitinib, a recently approved potent drug for first-line treatment of metastatic non-small cell lung cancer

Abstract

Dacomitinib (DAC) is the most recent drug approved drug for the first-line treatment of patients with metastatic non-small cell lung cancer. This study describes, for the first time, the development of a novel green and high-throughput microwell spectrophotometric assay (MW-SPA) for one-step determination of DAC. The assay was based on formation of a colored charge transfer complex between DAC, as electron donor, with 2,3-dichloro-3,5-dicyano-1,4-benzoquinone, as π-electron acceptor. Ultraviolet–visible spectrophotometry was used to characterize the complex and proposing the reaction mechanism. Under refined optimum reaction conditions, it was employed as a basis for the development of the proposed MW-SPA. The assay was conducted in 96-well assay plates, and the absorbances were measured by an absorbance plate reader. Validation of the assay was performed in accordance with guidelines of the International Council on Harmonization, and all validation parameters were acceptable. The limits of detection and quantitation of the MW-SPA were 1.2 and 3.7 μg/well, respectively. The assay was applied with great distinct success for determining DAC in its bulk form and vizimpro® tablets. The greenness of the assay was ascertained by three distinct metric tools, which conclusively demonstrated the adherence of the assay to principles of green analytical chemistry approach. Moreover, the assay has high throughput capacity as it can simultaneously process large number of micro-volume samples. In conclusion, the proposed MW-SPA is valuable for the rapid and routine determination of DAC for the purposes of quality control.