Comprehensive Review on Formulation, Characterization, and Analytical Validation of Mesoporous Silica Nanoparticles Loaded with Anticancer Drugs

Mesoporous silica nanoparticles (MSNs) have gained considerable attention as promising carriers for anticancer drug delivery due to their high surface area, tunable pore structure, and surface modifiability. These properties enable efficient drug loading, controlled release, and improved formulation performance compared to conventional chemotherapy systems. The present review focuses on the formulation of anticancer drug-loaded MSNs using the sol–gel method, along with their physicochemical characterization and analytical evaluation. Key characterization techniques such as SEM, TEM, BET analysis, zeta potential, FTIR, XRD, DSC, and TGA are discussed to confirm particle morphology, porosity, surface properties, and drug incorporation. Emphasis is placed on the development and validation of UV–Visible spectrophotometric and HPLC methods in accordance with ICH Q2(R1) guidelines for accurate estimation of drug content, entrapment efficiency, and in-vitro drug release from an analytical perspective. This review highlights the importance of validated analytical methods in ensuring the quality, reliability, and reproducibility of MSN-based anticancer drug delivery systems.