ENDOXIFEN CITRATE: A REVIEW ON ANALYTICAL METHOD AND VALIDATION

Gokulapriya A.* and Vetrichelvan T.

ABSTRACT

Endoxifen citrate is the anticancer drug, under the development for the treatment of estrogen receptor positive breast cancer and treatment of mania in bipolar disorder. It is a potent active metabolite of tamoxifen, has gained significant attention in recent years due its enhanced anti-estrogenic activity and therapeutic potential in hormone responsive breast cancer. Unlike, its parent compound, endoxifen exhibits a direct mechanism of action by binding with high affinity to estrogen receptors, leading to effective inhibition of estrogen mediated cell proliferation. This review provides a comprehensive overview of endoxifen citrate, encompassing its chemical structure, Pharmacokinetic, Pharmacodynamics and mechanism of action. The Clinical and Pharmaceutical analysis of this drug requires effective analytical procedures for mechanism of action and quality control and Pharmacodynamics and Pharmacokinetic studies as well as stability study. The literature from numerous journals pertaining to Pharmaceutical analysis and Pharmacology has been thoroughly reviewed, and instrumental analytical methods that were developed and used for determining the presence of a drug alone in bulk drugs, formulations, and biological fluids have been examined. This review covers the most recent many analytical methods including 2D NMR, chromatographic method including LC-MS, UPLC-MS and HPLC were reported.

Keywords: Endoxifen, development, anticancer, analytical method, 2D-NMR, LC-MS, UPLC-MS, HPLC.