HPLC Method for the Determination of Celecoxib in Human Plasma and its Applications in Pharmacokinetics and Bioequivalence Studies

A sensitive, precise and fast reverse phase HPLC method was developed and validated for quantitative analysis of celeeoxib in humlll plasma in order to carry out bioequivalence studies. Celeeoxib was extracted using liquid-liquid extraction method and analyzed on BDS Hypersil C8 (150 mm x 4.6 nun x 5 mum) column, with mobile phase of composition acetonitrile: water: triethyleamine (50: 50: 0.05). pH 5 was adjusted with acetic acid, delivered at a rate of 1.5 ml/min, using UV-detector at 254 nm. The standard curve was linear (r^2 = 0.9911) in the range of 0.032-2 mug/ml. Intra day and inter days expressed by relative standard deviation (R.S.D.) was less than 3 % and inaccuracy was less than 4 %. The extraction recovery of Celecoxib from human plasma was greater than 89 %. The assay has been used to analyze samples collected for the purpose of bioequivalencc studies of two brands of cclecoxib in healthy human volunteers. Furthennore, this method can be used to analyze samples of celecoxib collected in real clinical situations.