Quick and Simultaneous Analysis of Dissolved Active Pharmaceutical Ingredients and Formulation Excipients from the Dissolution Test Utilizing UHPLC and Charged Aerosol Detector

This study introduces a rapid and simultaneous analytical system for evaluating the dissolution of both active pharmaceutical ingredients (APIs) and formulation excipients from dissolution test samples. The system integrates Ultra-High Performance Liquid Chromatography (UHPLC) with charged aerosol detection (CAD) and PDA detectors. A key innovation is the use of two columns for size-exclusion chromatography (SEC), which enables the quick determination of various water-soluble polymers. To demonstrate its applicability, the system was tested with three model sustained-release tablets, each containing an API with different water solubility (propranolol, ranitidine, and cilostazol) within a polyethylene oxide (PEO) matrix. The dissolution behaviors observed for each API—propranolol dissolving consistent with PEO erosion, ranitidine releasing faster than PEO, and cilostazol releasing slower—highlight the system's precision in studying drug release mechanisms. The research emphasizes that optimizing the SEC column for efficient separation of APIs and excipients can significantly enhance the system's utility for drug formulation design and understanding drug release kinetics. This method provides a precise and valid tool for comprehensive dissolution behavior analysis.

This study introduces a rapid and simultaneous analytical system for evaluating the dissolution of both active pharmaceutical ingredients (APIs) and formulation excipients from dissolution test samples. The system integrates Ultra-High Performance Liquid Chromatography (UHPLC) with charged aerosol detection (CAD) and PDA detectors. A key innovation is the use of two columns for size-exclusion chromatography (SEC), which enables the quick determination of various water-soluble polymers. To demonstrate its applicability, the system was tested with three model sustained-release tablets, each containing an API with different water solubility (propranolol, ranitidine, and cilostazol) within a polyethylene oxide (PEO) matrix. The dissolution behaviors observed for each API—propranolol dissolving consistent with PEO erosion, ranitidine releasing faster than PEO, and cilostazol releasing slower—highlight the system's precision in studying drug release mechanisms. The research emphasizes that optimizing the SEC column for efficient separation of APIs and excipients can significantly enhance the system's utility for drug formulation design and understanding drug release kinetics. This method provides a precise and valid tool for comprehensive dissolution behavior analysis. Research Background and Significance The accurate and rapid analysis of both active pharmaceutical ingredients (APIs) and excipients in dissolution testing is critical for drug formulation development, quality control, and understanding drug release mechanisms. Traditional dissolution testing methods often focus primarily on APIs, neglecting the comprehensive assessment of excipients, which can significantly influence the drug release profile and bioavailability. The integration of Ultra-High Performance Liquid