A Review on Recent Advances in UV and RP-HPLC Method Development for Anticancer Drugs

Abstract

Cancer continues to be one of the leading causes of morbidity and mortality worldwide, creating a growing demand for accurate, reliable, and regulatory-compliant analytical methods for the quantification of anticancer drugs. Among the available techniques, UV–Visible spectrophotometry and Reverse Phase High-Performance Liquid Chromatography (RP-HPLC) remain the most widely used due to their simplicity, cost-effectiveness, sensitivity, and reproducibility. This review highlights recent advancements in the development and validation of UV and RP-HPLC methods for a broad range of anticancer agents, including alkylating agents, antimetabolites, taxanes, anthracyclines, platinum compounds, tyrosine kinase inhibitors, CDK4/6 inhibitors, monoclonal antibodies, and emerging targeted therapies. Key aspects of method development such as selection of mobile phase, detection wavelength, chromatographic conditions, and optimization strategies are discussed. Special emphasis is placed on method validation parameters in accordance with ICH Q2(R1) guidelines, including linearity, accuracy, precision, specificity, robustness, and system suitability. Additionally, recent trends such as green analytical chemistry, Quality-by-Design (QbD), UHPLC, and hyphenated techniques are addressed. This comprehensive review aims to support researchers, academicians, and pharmaceutical analysts in developing robust, sensitive, and eco-friendly analytical methods for routine quality control and regulatory submissions.