Sensitive and selective liquid chromatography-mass spectrometry method for the quantification of rosiglitazone in human plasma.
A sensitive and selective high-performance liquid chromatography-electrospray ionisation-tandem mass spectrometry (HPLC-ESI-MS-MS) method for determination of rosiglitazone in human plasma has been developed. After the addition of the internal standard, plasma samples were precipitated by acetonitrile. The compounds were separated on a proC18 column using a mixture of ammonium acetate buffer (0.02 M, pH 6.5) and acetonitrile (in the ratio of 47:53, v/v) as mobile phase. A Finnigan LCQdeca plus ion trap mass spectrometer connected to a Finnigan Surveyor HPLC was used to develop and validate the method. Linearity was established for the range of concentrations 1-1000 ng/ml with a coefficient of determination (r(2)) of 0.999. The intra-day accuracy for rosiglitazone ranged from 110.0 to 99.2% at low, medium and high levels. The inter-day accuracy was less than 15%. The lower limit of quantitation (LLOQ) was identified reproducible at 1.0 ng/ml with a precision of 5.7%. After validation, the method was used to study the pharmacokinetic profile of rosiglitazone in five healthy volunteers after administration of a single oral dose (4.0mg). The proposed method enabled the unambiguous evaluation and quantitation of rosiglitazone for pharmacokinetic, bioavailability or drug-drug interaction studies. A possible chromatography peak (m/z 121, its parent ion m/z 344) of N-demethyl rosiglitazone was observed at 3.49 min during determining rosiglitazone. This may be also a potential method for simultaneous determination of rosiglitazone and its metabolite N-demethyl rosiglitazone concentrations in plasma.
He
J
J
Pharmacogenetics Research Institute, Institute of Clinical Pharmacology, Central South University, 110 Xiang Ya Road, Changsha, Hunan 410078, China.
Hu
Y F
YF
Duan
L F
LF
Tan
Z R
ZR
Wang
L S
LS
Wang
D
D
Zhang
W
W
Li
Z
Z
Liu
J
J
Tu
J H
JH
Yao
Y M
YM
Zhou
Hong-Hao
HH
D000284:Administration, Oral; D000328:Adult; D001682:Biological Availability; D002851:Chromatography, High Pressure Liquid / Q000379:methods* / Q000592:standards; D016903:Drug Monitoring / Q000379:methods; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics; D008297:Male; D012015:Reference Standards; D012016:Reference Values; D015203:Reproducibility of Results; D000077154:Rosiglitazone; D012680:Sensitivity and Specificity; D021241:Spectrometry, Mass, Electrospray Ionization / Q000379:methods* / Q000592:standards; D053719:Tandem Mass Spectrometry / Q000379:methods* / Q000592:standards; D045162:Thiazolidinediones / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics
D007004:Hypoglycemic Agents; D045162:Thiazolidinediones; D000077154:Rosiglitazone