Abstract

A CRITICAL REVIEW OF ANALYTICAL METHODS FOR DETERMINATION OF ENZALUTAMIDE IN BULK AND DOSAGE FORM

Virendra Pawara* and Arvind Kokani

ABSTRACT

Enzalutamide, a second-generation androgen receptor inhibitor, serves as a fundamental treatment for metastatic castration-resistant prostate cancer. The intricate pharmacokinetics and metabolism of the drug require strong analytical methods for quality control, therapeutic monitoring, and pharmacokinetic profiling. Recent advancements have highlighted liquid chromatography-tandem mass spectrometry (LC-MS/MS) as the leading method due to its exceptional sensitivity and specificity, complemented by techniques such as HPLC, UV-visible spectroscopy, and electrochemical methods. Cutting-edge methods, such as principles of sustainable analytical chemistry and advancements in nanotechnology, have improved both efficiency and environmental safety. Validation studies have demonstrated precision,accuracy, and stability across various matrices under stress conditions, thereby ensuring adherence to regulatory standards. Furthermore, comparative dissolution studies of enzalutamide capsules available in India validated their pharmaceutical equivalence, reinforcing consistent therapeutic outcomes. This thorough review underscores the progress made in analytical methods for enzalutamide, focusing on their importance in clinical and pharmaceutical contexts for enhancing prostate cancer treatments.

Keywords: Enzalutamide (ENZ), Analytical Method, HPLC, Spectroscopy, LC-MS/MS.