A bioequivalence study of gliclazide based on quantification by high-performance liquid chromatography coupled with electrospray tandem mass spectrometry

International Journal of Clinical Pharmacology and Therapeutics

Volumn 45, Issue 3, 2007, Pages 175-185

  Mendes, G D ^a,b,c   Moreira, L D ^a   dos S Pereira, A ^b   Borges, A ^a,b   Yui, F ^a   Mendes, F D ^a,b   de Nucci, G ^a,b,c,d  

^a UNIVERSITY OF CAMPINAS   (Brazil)

^b Galeno Laboratory   (Brazil)

^c UNIVERSITY OF SÃO PAULO   (Brazil)

^d NONE   (Brazil)

Author keywords

Bioequivalence; Gliclazide; Healthy volunteer; Tandem mass spectrometry

Indexed keywords

ETHER; GLIBENCLAMIDE; GLICLAZIDE; HEXANE;

ADULT; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; CALIBRATION; CLINICAL TRIAL; CONTROLLED CLINICAL TRIAL; CONTROLLED RELEASE FORMULATION; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; DRUG DETERMINATION; DRUG DOSAGE FORM COMPARISON; DRUG HALF LIFE; DRUG METABOLISM; DRUG STRUCTURE; ELECTROSPRAY MASS SPECTROMETRY; FEMALE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; MALE; MAXIMUM PLASMA CONCENTRATION; NORMAL HUMAN; OPEN STUDY; QUANTITATIVE ANALYSIS; RANDOMIZED CONTROLLED TRIAL; REFERENCE VALUE; SENSITIVITY AND SPECIFICITY; TABLET FORMULATION; TANDEM MASS SPECTROMETRY; TIME TO MAXIMUM PLASMA CONCENTRATION; VALIDATION PROCESS;

EID: 33947231242     PISSN: 09461965     EISSN: None     Source Type: Journal    
DOI: 10.5414/CPP45175     Document Type: Article

References (12)

1. Delrat P, Paraire M, Jochemsen R. Complete bioavailability and lack of food-effect on pharmacokinetics of gliclazide 30 mg modified release in healthy volunteers. Biopharm Drug Dispos. 2002; 23: 151-157.
2. El-Enany N. Spectrofluorimetric and spectrophotometric determination of gliclazide in pharmaceuticals by derivatization with 4-chloro-7-nitrobenzo-2-oxa-1,3-diazole. J AOAC Int. 2003; 86: 209-214.
3. Holmes B, Heel RC, Brogden RN, Speight TM, Avery GS. Gliclazide. A preliminary review of its pharmacodynamic properties and therapeutic efficacy in diabetes mellitus. Drugs. 1984; 27: 301-327.
4. Hong SS, Lee SH, Lee YJ, Chung SJ, Lee MH, Shim CK. Accelerated oral absorption of gliclazide in human subjects from a soft gelatin capsule containing a PEG 400 suspension of gliclazide. J Control Release. 1998; 51: 185-192.
5. Kim H, Yun M, Kwon KI. Pharmacokinetic and pharmacodynamic characterization of gliclazide in healthy volunteers. Arch Pharm Res. 2003; 26: 564-568.
6. Najib N, Idkaidek N, Beshtawi M, Bader M, Admour I, Alam SM, Zaman Q, Dham R. Bioequivalence evaluation of two brands of gliclazide 80 mg tablets (Glyzide and Diamicron) in healthy human volunteers. Biopharm Drug Dispos. 2002, 23: 197-202.
7. Park JY, Kim KA, Kim SL, Park PW. Quantification of gliclazide by semi-micro high-performance liquid chromatography: application to a bioequivalence study of two formulations in healthy subjects. J Pharm Biomed Anal. 2004; 35: 943-949.
8. Rojanasthien N, Sugunta C, Rungapinan S, Kumsorn B, Sangdee C. Bioequivalence study of generic gliclazide and Diamicron formulations in healthy Thai male volunteers. Int J Clin Pharmacol Ther. 2003; 41: 323-330.
9. Rouini MR, Mohajer A, Tahami MH. A simple and sensitive HPLC method for determination of gliclazide in human serum. J Chromatogr B Analyt Technol Biomed Life Sci. 2003; 785: 383-386.
10. US Food and Drug Administration. Federal Register Part 320: Bioavailability and Bioequivalence Requirements; abbreviated applications; proposed revisions - FDA. Proposed rule. FED regist. 63: 64222-64228.
11. US Food and Drug Administration. In vivo bioequivalence guidances. Pharmacopeial Forum. 1993; 19: 6501-6508.
12. Zhong GP, Bi HC, Zhou S, Chen X, Huang M. Simultaneous determination of metformin and gliclazide in human plasma by liquid chromatography-tandem mass spectrometry: application to a bioequivalence study of two formulations in healthy volunteers. J Mass Spectrom. 2005; 40: 1462-1471.