Practical Applications of Monolithic Columns to Pharmaceutical Process Development

High performance liquid chromatography (HPLC) is among the most widely used analytical techniques in the process development of drug substances. With the goal of reducing analysis time, there has been considerable focus on high-speed HPLC separations. Recently, commercially available monolithic colu...

Full description

Saved in:
Bibliographic Details
Published in:Journal of liquid chromatography & related technologies 2005-02, Vol.28 (3), p.341-356
Main Authors: Liu, Yong, Antonucci, Vincent, Shen, Yi, Vailaya, Anant, Wu, Naijun
Format: Article
Language:English
Subjects:
Analysis
Analytical chemistry
Biological and medical sciences
Chemistry
Chromatographic methods and physical methods associated with chromatography
Exact sciences and technology
fast separations
General pharmacology
Medical sciences
monolithic columns
Other chromatographic methods
pharmaceuticals
Pharmacology. Drug treatments
process development
Reversed-phase liquid chromatography
Citations: Items that this one cites
Items that cite this one
Online Access:Get full text
Tags: Add Tag
No Tags, Be the first to tag this record!
Description
Summary:High performance liquid chromatography (HPLC) is among the most widely used analytical techniques in the process development of drug substances. With the goal of reducing analysis time, there has been considerable focus on high-speed HPLC separations. Recently, commercially available monolithic columns have proven to be one of the most promising developments in the area of fast chromatographic separations. In this work, pressure drop, column efficiency, and retention behavior of monolithic columns (Chromolith type) were evaluated and compared with those of conventional columns packed with porous stationary-phase particles. It was demonstrated that high-speed HPLC separations could be achieved with monolithic columns at acceptable pressure drops without significantly compromising column efficiency. The applications of monolithic columns in pharmaceutical process development, such as reaction monitoring, column fraction screening, and analysis of mother liquors and unstable analytes, are described with respect to the quality of separations, as well as, enhanced throughput and speed of analysis. It is concluded that the use of monolithic columns offers a significant advancement over currently available techniques in the high-speed and high-throughput analysis of pharmaceutical compounds. Some practical aspects in utilizing monolithic columns for fast separations are also discussed.
ISSN:1082-6076
1520-572X
DOI:10.1081/JLC-200044507