Liquid chromatography--mass spectrometry method for the determination of gliclazide in human plasma and application to a pharmacokinetic study of gliclazide sustained release tablets.
A sensitive and selective liquid chromatographic--mass spectrometric (LC-MS) method for the determination of gliclazide (CAS 21187-98-4) in human plasma has been developed. Sample treatment was based on protein precipitation with acetonitrile. Analytical determination was carried out on a C18 column interfaced with a triple quadrupole mass spectrometer. Positive electrospray ionization was employed as the ionization source. The mobile phase was acetonitrile-water containing 10 mmol/l ammonium acetate, pH 3.5 adjusted with acetic acid (75:25) at the flow rate of 1.0 ml/min. Both the analyte and the internal standard glipizide (CAS 29094-61-9) were detected by use of selected ion monitoring mode. The method was linear in the concentration range of 0.025-2.5 microg/mL. The lower limit of quantification (LLOQ) was 0.025 microg/mL. The intra- and inter-day relative standard deviation across three validation runs over the entire concentration range was less than 9.8%. The accuracy determined at three concentrations (0.05, 0.2 and 1.5 microg/mL for gliclazide) was within +/- 10.11% in terms of relative error (RE). The method herein described was successfully applied for the evaluation of pharmacokinetic profiles of gliclazide sustained release tablets in 18 healthy volunteers. The results show that AUC, Tmax, Cmax and T1/2 between the test formulation and reference formulation have no significant difference (P > 0.05). Relative bioavailability is 96.7.4 +/- 12.9%.
Wang
Cai-Yun
CY
Center for Instrumental Analysis, China Pharmaceutical University, Key Laboratory of Drug Quality Control and Pharmacovigilanc, Ministry of Education, Nanjing , The People's Republic of China. caiyun0930@hotmail.com
Zhang
Wei
W
Xiang
Bing-Ren
BR
Yu
Li-Yan
LY
Ma
Peng-Cheng
PC
D001682:Biological Availability; D002138:Calibration; D002851:Chromatography, High Pressure Liquid; D003692:Delayed-Action Preparations; D005907:Gliclazide / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics*; D006801:Humans; D006863:Hydrogen-Ion Concentration; D007004:Hypoglycemic Agents / Q000008:administration & dosage / Q000097:blood* / Q000493:pharmacokinetics*; D011786:Quality Control; D012015:Reference Standards; D015203:Reproducibility of Results; D021241:Spectrometry, Mass, Electrospray Ionization
D003692:Delayed-Action Preparations; D007004:Hypoglycemic Agents; D005907:Gliclazide