Abstract

A REVIEW ON METHOD DEVELOPMENT AND VALIDATION OF SELECTED ANTICANCER DRUG TUCATINIB BY USING DIFFERENT ANALYTICAL TECHNIQUES

Dr. Santhosh Illendula*, Varipally Sai Sindhu, Vootkuri Nihathi, Jeamoni Mahesh, Kurumeti Divya, Mothe Praneeth, Vusala Tejaswi, Dr. Suthakaran Raj

ABSTRACT

Tucatinib is a potent and selective tyrosine kinase inhibitor primarily used in the treatment of HER2-positive breast cancer. It selectively inhibits the kinase activity of human epidermal growth factor receptor 2 (HER2), thereby blocking HER2-mediated signalling pathways. Inhibition of HER2 prevents downstream activation of pathways involved in cell proliferation, survival, and tumour growth. Tucatinib is commonly used in combination with trastuzumab and capecitabine for advanced or metastatic HER2-positive breast cancer. Analytical method development is essential for the accurate identification, estimation, and quality control of tucatinib in pharmaceutical formulations. Various analytical techniques such as UV-visible spectroscopy, HPLC, HPTLC, LC-MS, and other chromatographic methods can be employed for its estimation. Method validation ensures the reliability, accuracy, precision, specificity, linearity, robustness, and sensitivity of the developed methods. This review focuses on the available analytical techniques reported for the determination of tucatinib and their important analytical parameters. The review also highlights the suitability of different methods for routine pharmaceutical analysis and quality assessment of tucatinib.

Keywords: Tucatinib, HER2, Tyrosine kinase inhibitor, Analytical method development, Method validation, HPLC, UV-Visible spectroscopy, LC-MS.