Quantification of gliclazide by semi-micro high-performance liquid chromatography: Application to a bioequivalence study of two formulations in healthy subjects

Journal of Pharmaceutical and Biomedical Analysis

Volumn 35, Issue 4, 2004, Pages 943-949

  Park, Ji Young ^a   Kim, Kyoung Ah ^a   Kim, Su Lyun ^a   Park, Pil Whan ^a  

^a Gachon University   (South Korea)

Author keywords

Bioequivalence; Gliclazide; Semi micro column

Indexed keywords

2 PROPANOL; ACETONITRILE; GLICLAZIDE; PHOSPHATE;

ACCURACY; ADULT; ANALYSIS OF VARIANCE; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CALCULATION; CALIBRATION; CLINICAL TRIAL; CONFIDENCE INTERVAL; CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; DRUG FORMULATION; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; HUMAN EXPERIMENT; NORMAL HUMAN; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; STATISTICAL ANALYSIS; STATISTICAL SIGNIFICANCE; ULTRAVIOLET RADIATION;

ADULT; ANALYSIS OF VARIANCE; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; CROSS-OVER STUDIES; GLICLAZIDE; HUMANS; THERAPEUTIC EQUIVALENCY;

EID: 2942612501     PISSN: 07317085     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jpba.2004.02.025     Document Type: Article

References (13)

1. Palmer K.J., Brogden R.N. Drugs. 46:1993;92-125
2. Holmes B., Heel R.C., Brogden R.N., Speight T.M., Avery G.S. Drugs. 27:1984;301-327
3. Campbell D.B., Lavielle R., Nathan C. Diabetes Res. Clin. Prac. 14:1991;S21-S36
4. Shiba T., Kajinuma H., Suzuki K., Hagura R., Kawai A., Katagiri H., Sando H., Shirakawa W., Kosaka K., Kuzuya N. Diabetes Res. Clin. Prac. 2:1986;301-306
5. Batch J., Ma A., Bird D., Noble R., Charles B., Ravenscroft P., Cameron D. Eur. J. Clin. Pharmacol. 38:1990;465-467
6. Maeda T., Yamaguchi T., Hashimoto M. J. Chromatogr. 223:1981;357-363
7. Kimura M., Kobayashi K., Hata M., Matsuoka A., Kitamura H., Kimura Y. J. Chromatogr. 183:1980;467-473
8. Igaki A., Kobayashi K., Kimura M., Sakoguchi T., Hashimoto M., Matsuoka A. Rinsho Byori. 34:1986;201-205
9. Sener A., Akkan A.G., Malaisse W.J. Acta Diabetol. 32:1995;64-68
10. Noguchi H., Tomita N., Naruto S., Nakano S. J. Chromatogr. 583:1992;266-269
11. Kobayashi K., Kimura M., Sakoguchi T., Hase A., Matsuoka A., Kaneko S. J. Pharm. Sci. 73:1984;1684-1687
12. Korean Guidelines for Bioequivalence Test, The Food and Drug Administration of Korea. Seoul, Korea, 1996.
13. Federal Register Part 320: Bioavailability and Bioequivalence Requirements, US Food and Drug Administration, Washington, DC, 1985.