A rapid and sensitive HPLC method for the analysis of celecoxib in human plasma: application to pharmacokinetic studies

Background and the purpose of the study: A suitable high-performance liquidchromatography (HPLC) method for determination of celecoxib levels in plasma is ofprime need for the pharmacokinetics and bioequivalence studies of celecoxib preparations.The present study describes a simple, rapid, sensitive, reliable, and economic HPLC methodfor determination of celecoxib in human plasma which is more feasible than reportedcelecoxib HPLC assays.Methods: The drug and internal standard were extracted using n-hexane /isoamyl alcohol(97:3) and analyzed on a C18 μ-Bondapak HPLC column with KH2PO4 (0.01M, pH= 4) -acetonitrile (60:40) as the mobile phase, at 260 nm. The method involved simple one-stepliquid-liquid extraction procedure with extraction recovery of greater than 90%.Results: The standard curve covering 0.01-2.0 μg/ml concentration range was linear. Thecoefficients of variation and relative errors for inter- and intra-day assay ranged from 5.67to 9.83 and 0.35 to 7.89 %, respectively.Conclusions: HPLC assay was performed isocratically on a reversed-phase column withUV detection. By this method a limit of quantification of 10 ng/ml of a sample size of 0.5ml is achieved which is comparable or even better than the reported methods. Thedeveloped method was applied to the analysis of celecoxib levels in plasma collected fromhealthy volunteers who participated in a pharmacokinetic study.