A sensitive and practical LC-MS/MS method for the determination of mizoribine in human serum and its bioequivalence study on Chinese healthy volunteers / 药学学报
Acta Pharmaceutica Sinica
;
(12): 1149-1154, 2010.
Article
Dans Anglais
| WPRIM
| ID: wpr-250649
ABSTRACT
A high-performance liquid chromatography/electrospray ionization tandem mass spectrometry (LC-ESI-MS/MS) method was developed and validated for the determination of mizoribine in human serum using thiamphenicol as internal standard (IS). The serum samples of mizoribine were precipitated with acetonitrile and separated by HPLC on a reversed phase C18 column with a mobile phase of 0.1% ammonium acetate water solution-methanol (4753, v/v). Mizoribine and IS were detected in the multiple reaction monitoring mode with precursor/product ion transitions of m/z 258.2/126.0 and 354.1/185.2, respectively. The calibration curves were linear over the range of 0.02-2 microg mL(-1) for mizoribine. The limit of quantification (LOQ) was 0.02 microg mL(-1) with acceptable precision and accuracy. The validated method was successfully applied for the evaluation of a bioequivalence study on Chinese healthy volunteers. The main pharmacokinetics parameters after oral administration of 100 mg mizoribine test or reference formulation were as follows Cmax (1.00 +/- 0.21), (1.00 +/- 0.22) microg mL(-1); AUC(0-infinity) (6.72 +/- 1.39), (6.48 +/- 1.44) microg h mL(-1); t1/2 (2.77 +/- 0.26), (2.66 +/- 0.29) h; tmax (2.95 +/- 0.78), (2.84 +/- 0.50) h.
Texte intégral:
Disponible
Indice:
WPRIM (Pacifique occidental)
Sujet Principal:
Ribonucléosides
/
Sang
/
Pharmacocinétique
/
Équivalence thérapeutique
/
Intervalles de confiance
/
Chromatographie en phase liquide à haute performance
/
Aire sous la courbe
/
Spectrométrie de masse ESI
/
Asiatiques
/
Antienzymes
Type d'étude:
Etude diagnostique
/
Étude pronostique
Limites du sujet:
Adulte
/
Humains
/
Mâle
langue:
Anglais
Texte intégral:
Acta Pharmaceutica Sinica
Année:
2010
Type:
Article
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