Published:Journal of Chromatographic Science,
ISSN 0021-9665Volume
40, Number 1, January 2002, pp. 26-28
A Rapid and Sensitive High-Performance Liquid Chromatography
Assay for Rofecoxib in Human Serum
M.K.
Aravind[1], R. Prescilla[2], and J.P. Ofenstein[1]
[1]Wayne State University School of Medicine and
[2]Children’s Hospital of Michigan, Department of Pediatrics, Division of
Clinical Pharmacology and Toxicology, 3901 Beaubien Blvd., Detroit, MI 48201.
Rofecoxib is a selective cyclooxygenase (COX)-2 inhibitor that
is approved for the treatment of acute pain and osteoarthritis in adults. A
sensitive and rapid high-performance liquid chromatographic (HPLC) method of
determining rofecoxib in human serum is described. Alkalinized plasma samples
are extracted into an organic solvent containing an internal standard and evaporated
under nitrogen. The dried sample residues are reconstituted with mobile phase
and analyzed by HPLC. The method uses 100 µL of the sample and is linear
from 20 to 2000 ng/mL of rofecoxib. Precision and accuracy studies are performed.
Stability of the drug in serum over four weeks is documented. This new method
is simple, sensitive, precise, and accurate. Its use will translate into faster
laboratory turnaround time, and the small sample volume required (100 µL)
makes this assay suitable for pediatric patients. This assay will expedite pharmacokinetic
studies and the therapeutic drug monitoring of rofecoxib and possibly other
COX-2 inhibitors.
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