Core-shell column Tanaka characterization and additional tests using active pharmaceutical ingredients.

Area of Science:

• Analytical Chemistry
• Chromatography Science

Background:

• Core-shell particles are increasingly utilized in fast liquid chromatography (FLC) due to their performance advantages.
• They consist of a solid core with an outer porous shell, offering reduced back pressure compared to fully porous particles.
• Their application in pharmaceutical analysis is growing, necessitating thorough characterization.

Purpose of the Study:

• To characterize 17 commercially available core-shell C18 columns from various vendors.
• To evaluate the batch-to-batch reproducibility of core-shell columns using active pharmaceutical ingredients (APIs).
• To compare the efficiency of core-shell particles with sub-2 µm fully porous materials.

Main Methods:

• Characterization of 17 core-shell C18 columns (dimensions: 50 mm × 2.1 mm to 100 mm × 3 mm; particle sizes: 1.6–2.7 µm) using Tanaka test protocols.
• Investigation of batch-to-batch reproducibility using four selected APIs under isocratic elution.
• Performance comparison with a fully porous BEH C18 (1.7 µm) column.

Main Results:

• Core-shell columns demonstrated comparable performance to sub-2 µm fully porous particles.
• Batch-to-batch reproducibility was investigated for different core-shell column types under isocratic and gradient elution.
• The efficiency of 2.6–2.7 µm core-shell particles was confirmed to be comparable to sub-2 µm fully porous materials.

Conclusions:

• Core-shell C18 columns are a viable option for fast liquid chromatography in pharmaceutical analysis.
• Their performance and reproducibility support their adoption in the market.
• These particles offer a balance of high efficiency and low back pressure.