High performance liquid chromatographic determination of cox-2 inhibitor rofecoxib in human plasma.
J Indian Med Assoc
;
2003 Aug; 101(8): 486-8
Article
Dans Anglais
| IMSEAR
| ID: sea-103759
ABSTRACT
A convenient, sensitive and simple method for the determination of rofecoxib in human plasma is presented. The analytical technique is based on reversed phase high performance liquid chromatography coupled with UV detector (Knauer, Germany) set at 272 nm. The retention time of rofecoxib after recovery from plasma, was 8.9 minutes. The method has been validated over a linear range of 50-450 ng/ml from plasma. After validation the method was used to study the pharmacokinetic profile of rofecoxib in 6 healthy volunteers as per DCGI guidelines after administration of a single oral dose (50 mg). The extraction efficiency from plasma varied from 93.95-99.58%. The minimum quantifiable concentration was set at 50 ng/ml (% CV < 10%). The pharmacokinetic parameters were Cmax = 318.58 +/- 30.65 ng/ml at tmax = 2.66 +/- 0.25 hours, AUC0-t = 4007.88 +/- 438.32 ng hour/ml, AUC0-yen = 5454.66 +/- 822.29 ng hour/ml, Kel = 0.0433 +/- 0.0067/hour, and t1/2 = 16.36 +/- 2.89 hours.
Texte intégral:
Disponible
Indice:
IMSEAR (Asie du Sud-Est)
Sujet Principal:
Normes de référence
/
Sulfones
/
Humains
/
Reproductibilité des résultats
/
Chromatographie en phase liquide à haute performance
/
Inhibiteurs des cyclooxygénases
/
Aire sous la courbe
/
Lactones
Type d'étude:
Étude pronostique
langue:
Anglais
Texte intégral:
J Indian Med Assoc
Année:
2003
Type:
Article
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