Modern Trends in Pharmaceutical Analysis: Integration of Hplc, Uplc, Uv, and Sec-malls for Drug Product Evaluation
Year: 2026
Type: article
Abstract: Modern pharmaceutical analysis increasingly relies on advanced multidimensional analytical techniques for comprehensive characterization of drug substances, drug products, biopharmaceuticals, and nanomedicine formulations. High-Performance Liquid Chromatography (HPLC), Ultra-Performance Liquid Chromatography (UPLC), UV-visible spectroscopy, and Size Exclusion Chromatography coupled with Multi-Angle Laser Light Scattering (SEC-MALLS) have emerged as highly powerful analytical platforms because of their sensitivity, selectivity, reproducibility, and broad pharmaceutical applicability. HPLC and UPLC are extensively utilized for assay determination, impurity profiling, dissolution testing, degradation studies, stability-indicating analysis, and pharmaceutical quality control, while UV-visible spectroscopy provides rapid and economical quantitative estimation of pharmaceutical compounds containing chromophoric functional groups. SEC-MALLS additionally enables absolute molecular weight determination, aggregation profiling, conformational analysis, and structural characterization of proteins, monoclonal antibodies, biosimilars, nanoparticles, liposomes, and advanced drug delivery systems without dependence on calibration standards. Integration of orthogonal analytical techniques significantly improves analytical reliability, multidimensional characterization capability, impurity identification, and structural elucidation in complex pharmaceutical formulations. The present review comprehensively discusses the principles, instrumentation, pharmaceutical applications, analytical advantages, method development strategies, validation requirements, regulatory significance, and future perspectives of HPLC, UPLC, UV-visible spectroscopy, and SEC-MALLS in modern pharmaceutical analysis. Particular emphasis is placed on multidetector analytical systems, integrated analytical workflows, pharmaceutical quality assessment, biosimilar evaluation, nanotechnology applications, and regulatory quality control. Emerging advancements involving AI-assisted analytics, automated multidetector platforms, high-resolution chromatography, and real-time process monitoring are also highlighted.
Institution: Lupin Pharmaceuticals (United States)
Language: English
Subfield: Analytical Chemistry
Field: Chemistry
Domain: Physical Sciences
Open Access status: diamond
OpenAlex ID: W7218154497