Quantitation of niflumic acid in human plasma by high-performance liquid chromatography with ultraviolet absorbance detection and its application to a bioequivalence study of talniflumate tablets

Journal of Chromatography B: Analytical Technologies in the Biomedical and Life Sciences

Volumn 821, Issue 2, 2005, Pages 215-220

  Lee, H W ^a   Won, K J ^a   Cho, S H ^a   Ha, Y H ^a   Park, W S ^a   Yim, H T ^a   Baek, M ^b   Rew, J H ^a   Yoon, S H ^c   Yim, S V ^c   Chung, J H ^c   Lee, K T ^a  

^a Kyung Hee University   (South Korea)

^b Korea Food and Drug Administration   (South Korea)

^c Kyung Hee University Hospital   (South Korea)

Author keywords

Bioequivalence test; High performance liquid chromatography (HPLC); Niflumic acid; Talniflumate; Validation

Indexed keywords

ACETONITRILE; BIODEGRADATION; BLOOD; CHROMATOGRAPHIC ANALYSIS; METABOLITES; METHANOL; ORGANIC ACIDS; PH EFFECTS; SEPARATION; ULTRAVIOLET RADIATION;

CHROMATOGRAPHIC SEPARATION; FREEZERS; HUMAN PLASMAS; NIFLUMIC ACID;

HIGH PERFORMANCE LIQUID CHROMATOGRAPHY;

ACETIC ACID; ACETONITRILE; BENZOFURAN DERIVATIVE; DRUG METABOLITE; INDOMETACIN; METHANOL; NIFLUMIC ACID; PALIMA; TALNIFLUMATE; UNCLASSIFIED DRUG; WATER;

ACCURACY; ADULT; ANALYTIC METHOD; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CHEMICAL COMPOSITION; CLINICAL TRIAL; COMPARATIVE STUDY; CONCENTRATION (PARAMETERS); CONTROLLED CLINICAL TRIAL; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BLOOD LEVEL; DRUG DEGRADATION; DRUG DETERMINATION; DRUG STABILITY; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; INSTRUMENTATION; MALE; NORMAL HUMAN; PH; PRECIPITATION; PRIORITY JOURNAL; RANDOMIZED CONTROLLED TRIAL; SEPARATION TECHNIQUE; STANDARD; STORAGE; TABLET; ULTRAVIOLET RADIATION; VALIDATION PROCESS;

ADULT; BENZOFURANS; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DRUG STABILITY; HUMANS; MALE; NIFLUMIC ACID; PYRIDINES; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; SPECTROPHOTOMETRY, ULTRAVIOLET; THERAPEUTIC EQUIVALENCY;

EID: 20444492468     PISSN: 15700232     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jchromb.2005.05.008     Document Type: Article

References (13)

1. S.C. Sweetman Martindale, The Extra Pharmacopoeia 33rd ed. 2002 Royal Pharmaceutical Society of Great Britain p. 62
2. M. Los, J.E. Boned, and C. Piccinali Farmaco 36 1981 372
3. G. Houin, F. Bree, and J.P. Tillement J. Chromatogr. 223 1981 351
4. Korea Food & Drug Administration, The Standard Protocols of Bioequivalence Test, 2002, p. 226.
5. H.J. Kim, Y.H. Han, S.J. Chung, M.H. Lee, and C.K. Shim Arch. Pharm. Res. 19 1996 297
6. P. Gowik, B. Jiilicher, and S. Uhlig J. Chromatogr. B 716 1998 221
7. A. Avegerinos, and S. Malamataris J. Chromatogr. 533 1990 271
8. C. Guechot, and P. Nicolle J. Chromatogr. 303 1984 440
9. D. Hauschke, V.W. Steinijans, and E. Diletti Int. J. Clin. Pharmacol. Ther. Toxicol. 28 1990 72
10. H.U. Schulz, and V.W. Steinijans Int. J. Clin. Pharmacol. Ther. Toxicol. 30 Suppl. S1 1992
11. KFDA Guidance for Industry, Statistical Approaches to Establishing Bioequivalence, Bioequivalence Division, Pharmacology Department, National Institute of Toxicology Department, 2003, Website: http://www.kfda.go.kr/.
12. Y.J. Lee, Y.G. Kim, M.G. Lee, S.J. Chung, M.H. Lee, and C.K. Shim Yakhakhoeji 44 2000 308
13. FDA Guidance for Industry, Statistical Approaches to Establishing Bioequivalence, US Department of health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER), 2001, Website: http://www.fda.gov/cder/guidance/index.htm.