ANALYTICAL METHOD DEVELOPMENT AND VALIDATION FOR ANTI-CANCER DRUGS USING HPLC: A REVIEW
K. Pravalika*, B. Gayatri, M. Srikanth Reddy, Arunabha Mallik
ABSTRACT
High-performance liquid chromatography (HPLC) plays an indispensable role in the analytical characterization of anti-cancer drugs due to their structural complexity, narrow therapeutic index, and stringent regulatory requirements. Anti-cancer agents—including alkylating agents, antimetabolites, topoisomerase inhibitors, taxanes, tyrosine kinase inhibitors (TKIs), monoclonal antibody fragments, and novel targeted therapies—require robust, selective, and stability-indicating analytical methods for quality control and therapeutic monitoring. This review summarizes key strategies for method development and validation of anti-cancer drugs using HPLC. Detailed emphasis is placed on chromatographic principles, physicochemical considerations of drugs, column and mobile phase selection, assay development, impurity profiling, bioanalytical sample preparation, and forced degradation studies. Furthermore, this review discusses validation parameters according to ICH, challenges in analyzing cytotoxic compounds, and modern advancements including UHPLC, LC-MS-hyphenation, green analytical chemistry, and Analytical Quality by Design (AQbD). Future perspectives highlight the need for eco-friendly methods, miniaturized formats, and highly selective detection approaches for new-generation targeted anti-cancer agents.
Keywords: HPLC, Anti-cancer drugs, Method development, Validation, Stability-indicating methods, AQbD, Impurity profiling, Oncology analytics.
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