title: Development of simple and rapid LC-MS/MS method for determination of celecoxib in human plasma and its application to bioequivalence study.
abstract: A suitable liquid chromatography tandem mass spectrometry (LC-MS/MS) method to determine celecoxib in human plasma is needed for bioequivalence and pharmacokinetic studies of celecoxib preparations. The present study describes a simple, rapid, reproducible, and reliable LC-MS/MS method to determine celecoxib concentrations in human plasma. After one-step liquid-liquid extraction (LLE) using methyl tert-butyl ether (MTBE), celecoxib and atorvastatin (internal standard, IS) were eluted on a Luna HILIC column with an isocratic mobile phase, consisting of 10mM ammonium formate buffer (adjusted to pH 3.0 with formic acid):methanol (5:95, v/v) at a flow rate of 0.2 mL/min. The achieved lower limit of quantitation (LLOQ) was 10 ng/mL (S/N>10) and the standard calibration curve for celecoxib was linear (correlation coefficients were >0.9995) over the studied concentration range (10-2000 ng/mL). The inter- and intra-assay coefficients of variation ranged from 1.15% to 4.93% and 1.08% to 7.81%, respectively. The chromatographic run time for each plasma sample was <2 min. The developed method was successfully applied to a bioequivalence study of celecoxib in healthy Korean male volunteers.
authors: College of Pharmacy, Kyung Hee University, Hoegi-Dong, Dongdaemun-Gu, Seoul 130-701, Republic of Korea.
authors: Mi-Sun
authors: MS
authors: Park
authors: Wang-Seob
authors: WS
authors: Shim
authors: Sung-Vin
authors: SV
authors: Yim
authors: Kyung-Tae
authors: KT
authors: Lee
mesh_terms: D000068579:Celecoxib; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D018592:Cross-Over Studies; D004355:Drug Stability; D006801:Humans; D016014:Linear Models; D059625:Liquid-Liquid Extraction; D008297:Male; D011720:Pyrazoles / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics; D015203:Reproducibility of Results; D056910:Republic of Korea; D013449:Sulfonamides / Q000097:blood* / Q000737:chemistry / Q000493:pharmacokinetics; D053719:Tandem Mass Spectrometry / Q000379:methods*; D013810:Therapeutic Equivalency
chemical_list: D011720:Pyrazoles; D013449:Sulfonamides; D000068579:Celecoxib