Evaluation of monolithic HPLC columns for various pharmaceutical separations: method transfer from conventional...

Area of Science:

• Analytical Chemistry
• Chromatography

Background:

• Conventional particle-packed C18 columns are widely used for pharmaceutical analysis.
• Transferring established methods to new column technologies can present challenges.

Purpose of the Study:

• To evaluate the successful transfer of existing chromatographic methods to monolithic Chromolith Performance RP-18e columns.
• To assess the performance, precision, and repeatability of monolithic columns for drug analysis.
• To compare the separation efficiency of monolithic versus conventional columns.

Main Methods:

• Established chromatographic methods for pilocarpine, propranolol, glibenclamide, glimepiride, and insulin were adapted for Chromolith Performance RP-18e columns.
• Method transfer involved adjusting mobile phase composition (acetonitrile content for insulin).
• Intraday and interday precision (retention time, peak area) and batch-to-batch repeatability were evaluated.

Main Results:

• Successful method transfer was achieved for all analytes, with minor mobile phase adjustment for insulin.
• Chromolith Performance columns demonstrated precision with relative standard deviation (RSD%) < 1.1% for retention time and peak area.
• Batch-to-batch repeatability showed RSD% < 1.3% for monolithic columns.
• Superior resolution was consistently obtained with monolithic columns compared to conventional columns across various flow rates (1-9 ml/min).

Conclusions:

• Monolithic Chromolith Performance RP-18e columns are suitable for transferring and executing established chromatographic methods for drug analysis.
• These columns offer excellent precision, repeatability, and enhanced separation efficiency.
• The use of monolithic columns can lead to improved chromatographic resolution for pharmaceutical compounds and their related products.