Bioequivalence and pharmacokinetic study of glipizide by HPLC-MS/MS
- Author:
Xing-Wei WU
1
Author Information
- Publication Type:Journal Article
- Keywords: Bioequivalence; Glipizide; HPLC-MS/MS; Pharmacokinetics
- From: Chinese Pharmaceutical Journal 2013;48(14):1204-1208
- CountryChina
- Language:Chinese
- Abstract: OBJECTIVE: To establish a simple and sensitive method of high performance liquid chromatography - tandem mass spectrometry (HPLC-MS/MS) for the determination of glipizide in human plasma and to calculate the pharmacokinetic parameters and evaluate the bioequivalence of two glipizide preparations in healthy Chinese volunteers. METHODS: A two-periods, randomized, crossover trial design was used. Twenty-four subjects took the test and reference preparations at the dose of 5 mg, and glipizide plasma concentration was determined by HPLC-MS/MS. Pharmacokinetic parameters were calculated and bioequivalence was evaluated. RESULTS: The mean pharmacokinetic parameters of glipizide after adminstration of 5 mg of test or reference preparations were as follows: ρmax were (251.25±61.94) and (240.13±52.43) μg·L-1, t1/2 were (4.85±1.39) and (5.08±1.76) h, tmax were (3.35±1.22) and (3.38±1.35) h, and AUC0-tn were (1561.44±475.73) and (1588.82±507.40) μg·h·L-1, respectively. CONCLUSION: The HPLC-MS/MS method is sensitive and simple, and can be used for the determination of glipizide plasma concentration. Statistical analysis of the pharmacokinetic parameters in heathy subjects indicated that the two preparations of glipizide are bioequivalent.
