THE APPLICABILITY OF 2.7 μm SOLID-CORE COLUMNS FOR HIGH THROUGHPUT ANALYSIS

Significance of the Topic

High-throughput chromatographic analysis is essential in pharmaceutical quality control and research, enabling rapid batch release and method development. The introduction of 2.7 µm solid-core particles offers a balance between high efficiency and manageable backpressure, making them attractive for scaling existing methods and accelerating routine analyses.

Objectives and Overview of the Study

This work evaluates the use of Waters CORTECS 2.7 µm solid-core C18 columns for transferring a validated abacavir assay and its four related substances from a conventional 5 µm fully porous 4.6 × 150 mm format to a 4.6 × 75 mm format. Key aims include maintaining chromatographic resolution, reducing analysis time, and assessing column robustness under minimal sample preparation.

Methodology and Instrumentation

The original method employed a Waters Alliance HPLC system with UV detection at 254 nm. Mobile phase A was 0.1 % TFA in water and phase B was 85 % methanol in water. The method development followed established scaling equations for column length, particle size, flow rate, gradient time, and injection volume to achieve equivalent chromatographic conditions on the smaller column. Key parameters:

• Original column: 4.6 × 150 mm, 5 µm C18 fully porous, 1.0 mL/min, 8 µL injection
• Scaled column: 4.6 × 75 mm, 2.7 µm CORTECS C18 solid-core, 1.85 mL/min, 4 µL injection

Main Results and Discussion

Resolution between critical peak pairs was maintained or improved on the scaled column, with USP resolution values of 2.7 and 4.1 compared to 2.7 and 3.3 on the original. Run time decreased by approximately fourfold, from 44.9 min to 12.1 min. Backpressure remained within instrument limits despite higher flow rates. A robustness study with 1000 injections of precipitated plasma demonstrated negligible pressure increase, highlighting the column’s resistance to fouling.

Benefits and Practical Applications

The CORTECS 2.7 µm solid-core columns enable:

• Transfer of existing methods from 5 µm fully porous formats with minimal revalidation
• Substantial throughput increases without compromising resolution
• Efficient operation at higher flow rates under standard HPLC pressures
• Reliable performance in assays with limited sample cleanup

Future Trends and Potential Applications

Solid-core technology is poised for broader application in pharmaceutical and bioanalytical labs. Emerging trends include integration with UHPLC systems, multidimensional separations, online sample cleanup modules, and AI-driven method optimization. Continued improvements in stationary phase design may further reduce analysis times and enhance selectivity for complex matrices.

Conclusion

CORTECS 2.7 µm solid-core C18 columns provide a robust and efficient platform for high-throughput HPLC analyses. They preserve chromatographic performance while dramatically reducing run times and handling challenging sample matrices. Adoption of this technology can streamline routine workflows and support accelerated development pipelines.

Reference

1. J.W. Dolan, LCGC North Am. 32(2), 98-102 (2014)
2. J.W. Dolan, LCGC North Am. 32(3), 188-193 (2014)