Reliability of computer-assisted method transfer between several column dimensions packed with 1.3-5μm core-shell...

Area of Science:

• Analytical Chemistry
• Chromatography

Background:

• Method transfer in chromatography is crucial for reproducibility and efficiency.
• Superficially porous particles (SPPs) offer advantages in speed and efficiency for RPLC.
• Optimizing and transferring methods across different instruments and column configurations can be challenging.

Purpose of the Study:

• To evaluate the automatic transfer of RPLC methods between different column dimensions and instruments using commercial modeling software.
• To assess the reliability of method transfer for loratadine and its impurities using state-of-the-art columns packed with SPPs.
• To validate the accuracy of modeling software predictions for gradient conditions during method transfer.

Main Methods:

• Utilized commercial modeling software for RPLC method development and transfer.
• Employed state-of-the-art columns with superficially porous particles (SPPs) of varying sizes (1.3, 1.7, 2.6, and 5 μm).
• Tested method transfer across different column dimensions (length, inner diameter) and LC instruments with varying dwell volumes.

Main Results:

• Achieved a fast baseline separation of loratadine and impurities with high resolution (Rs,min=2.49) on a 50mm×2.1mm, 1.3μm column.
• Successfully transferred the method to columns with larger particle sizes (1.7 and 2.6μm), maintaining selectivity and retention but widening peaks.
• Demonstrated excellent prediction accuracy for gradient conditions during method transfer, with average retention time errors of -0.11% and 0.45% for different column configurations.

Conclusions:

• Commercial modeling software is highly effective for the automatic transfer of RPLC methods between diverse column dimensions and instruments.
• The study validates the use of SPPs and modeling software for robust and reliable chromatographic method transfer.
• This approach enhances efficiency and reproducibility in analytical laboratories by simplifying method implementation on different LC systems.