Page 55 - BR20828_E Accucore 0713S

Technical Note 20668
Assessment of the Stability of 4 μm
Solid Core Particles for the Analysis of
Non-Steroidal Anti-Inflammatory Drugs
D. Foley, Thermo Fisher Scientific, Runcorn, Cheshire, UK
Introduction
Thermo ScientificTM Accucore TM XL HPLC columns use
Core Enhanced TechnologyTM to facilitate fast and highly
efficient separations. The 4 μm diameter particles are not
totally porous, but instead have a solid core and a porous
outer layer. The optimized phase bonding creates a series
of high coverage, robust phases. The tightly controlled
4 μm diameter of Accucore particles results in lower
backpressures than typically seen with fully porous
particles of the same diameter. The nature of the Accucore
XL particles provide an improvement in performance of
an analysis compared to that seen on columns using fully
porous 3 µm and 5 µm particles.
Stability of a column is of critical importance in obtaining
high quality data. Deterioration in column performance
can result in batch and validation failures that can effect
timelines and result in loss of both time and money.
Therefore, a great deal of value is placed on showing that
columns remain reproducible when being used for
extended periods of time. An analytical method was
developed to enable the assessment of Accucore XL
HPLC column stability.
Key Words
Accucore XL, column stability, fused core, superficially porous, solid core,
ibuprofen
Abstract
The analysis of non-steroidal, anti-inflammatory drugs on a 4 µm solid
core C8 HPLC column is described. A method was created using isocratic
conditions for separation to demonstrate column stability. The column
was proven to remain stable following 2,200 injections and 45,000 column
volumes of a test mixture containing naproxen, fenoprofen, and ibuprofen.
Experimental Details
Sample Preparation
Primary standards of theophylline, naproxen, fenoprofen, and
ibuprofen were prepared separately in methanol at a concentration of
1000 µg/mL. A working standard was prepared by preparing a
10 mL solution of Ibuprofen, fenoprofen, theophylline, and naproxen
by adding 1 mL ibuprofen, 0.5 mL fenoprofen, 0.5 mL theophylline,
and 0.025 mL naproxen primary standards to 1.975 mL acetonitrile
and 6 mL 20 mM ammonium formate, pH 3.