Cost-effective routine pharmaceutical testing using radial flow stream splitting HPLC columns: Quantitative analysis and performance metrics in the analysis of over-the-counter drugs

The demand for rapid and reliable analytical methods in the pharmaceutical industry continues to grow, with Ultra-/High-Performance Liquid Chromatography (U/HPLC) remaining the gold standard for impurity profiling, quantification of active pharmaceutical ingredients, and degradation product analysis. However, traditional HPLC methods are often constrained by pressure limitations at higher flow rates, which can hinder analytical throughput. While recent advancements in column technology have improved performance, they typically exacerbate pressure-related challenges. In this study, we evaluate a novel column technology designed to address these limitations by enabling high-resolution separations at reduced pressures and increased flow rates. Our findings demonstrate that the column, when operated in Radial Flow Stream Splitting (RFS) mode, maintains quantitative accuracy and repeatability while achieving up to a 120 % improvement in separation efficiency and a 30 % reduction in backpressure compared to conventional operation. By way of assaying over-the-counter medication, we have found no difference in the quantitative reliability of the assay when in RFS vs stock mode, despite reducing the analysis time by up to 40 %.