FDA refuses companies' request to drop ulcer warning.

A rapid, sensitive and reproducible HPLC method was developed and validated for the analysis of celecoxib in human plasma. The analysis was carried out on a monolithic silica column using UV detection at 254 nm. The assay enables the measurement of celecoxib for therapeutic drug monitoring with a minimum quantification limit of 10 ng ml(-1). The method involves simple, one-step extraction procedure, and analytical recovery was 100.5 +/- 1.3%. The calibration curve was linear over the concentration range of 10-800 ng ml(-1). The coefficients of variation for inter-day and intra-day assay were found to be less than 8%. We also demonstrate the applicability of this method for pharmacokinetic studies in humans.

Celecoxib↗

PubMed2006

Simultaneous determination of celecoxib, meloxicam, and rofecoxib using capillary electrophoresis with surfactant and application in drug formulations.

A simple and selective CE using surfactant with UV detection is described for the simultaneous determination of selective cyclooxygenase-2 inhibitors, celecoxib, meloxicam, and rofecoxib. The simultaneous analysis of celecoxib, meloxicam, and rofecoxib was performed in Tris buffer (10 mM; pH 11) with 60 mM sodium octane-sulfonate and 20% ACN as an anionic surfactant and organic modifier, respectively. Under this condition, good separation with high efficiency and the required short analysis time is achieved. The linear ranges of the method for the determination of celecoxib, meloxicam, and rofecoxib were over 5-100 microg/mL; the detection limits at 200 nm (S/N = 3; injection 3.45 kPa, 5 s) were 2, 1, and 1 microg/mL, respectively. The small amount of sample required and the expeditiousness of the procedure allow content uniformity to be determined in individual pharmaceutical products.

Celecoxib↗