Method Development for Antibiotics in Medical Devices
This medical device manufacturer wanted to begin in-house testing of antibiotics
in a medical device during manufacturing. If successful, they could realize
substantial cost-savings compared to the use of an independent laboratory
ACCTA, Inc. provided assistance in selection of appropriate equipment.
Then we helped train the staff to use both the software and hardware.
Finally, we coordinated method development and method validation.
An efficient method was developed to provide the necessary sensitivity
and selectivity. As shown in the chromatogram below, analysis was complete
in 15 minutes. We were able to easily separate one related impurity and
partially separate an isomer of the other analyte (better separation was
possible but not needed for this application, since only the total amount
was of interest). The solution preparation procedures and mobile phase
were much simpler than the corresponding USP methods. The polar embedded
phase provided better selectivity and retention than a standard reverse
phase column, and since we used a smaller bore column, we were able reduce
solvent consumption by 60 %, compared to a standard column.
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