Direct injection, column switching-liquid chromatographic technique for the estimation of rabeprazole in bioequivalence study

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

Volumn 813, Issue 1-2, 2004, Pages 247-254

  Singh, Sonu Sundd ^a   Jain, Manish ^a   Shah, Hiten ^a   Gupta, Sapna ^a   Thakker, Purav ^a   Shah, Ruchy ^a   Lohray, Braj Bhushan ^a  

^a ZYDUS RESEARCH CENTRE   (India)

Author keywords

Human plasma; Rabeprazole; Validation and bioequivalence

Indexed keywords

BIOANALYTICAL METHOD; CONCENTRATION RANGE; HUMAN PLASMA; RABEPRAZOLE;

PHARMACOKINETICS; PLASMAS; SWITCHING; THERMAL EFFECTS; ULTRAVIOLET RADIATION;

LIQUID CHROMATOGRAPHY;

RABEPRAZOLE; ZALEPLON;

ACCURACY; ANALYTIC METHOD; ARTICLE; BIOEQUIVALENCE; BLOOD SAMPLING; CONCENTRATION (PARAMETERS); CORRELATION COEFFICIENT; ELUTION; ENVIRONMENTAL TEMPERATURE; HIGH PERFORMANCE LIQUID CHROMATOGRAPHY; HUMAN; LIQUID CHROMATOGRAPHY; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; SENSITIVITY AND SPECIFICITY; TEMPERATURE DEPENDENCE; THAWING;

2-PYRIDINYLMETHYLSULFINYLBENZIMIDAZOLES; BENZIMIDAZOLES; CALIBRATION; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; HUMANS; OMEPRAZOLE; REFERENCE STANDARDS; REPRODUCIBILITY OF RESULTS; SENSITIVITY AND SPECIFICITY; SPECTROPHOTOMETRY, ULTRAVIOLET; THERAPEUTIC EQUIVALENCY;

VIOLA (ANGIOSPERM);

EID: 8844264548     PISSN: 15700232     EISSN: None     Source Type: Journal    
DOI: 10.1016/j.jchromb.2004.09.053     Document Type: Article

References (13)

1. H.D. Langtry, and A. Markham Drugs 58 4 1999 725
2. Pariet (Rabeprazole, 10 mg and 20 mg) electronic package insert, Jannsen-Cilag™ Eisai Co. Ltd., Tokyo, Japan.
3. S. Yasuda, A. Ohnishi, T. Ogawa, Y. Tomono, J. Hasegawa, H. Nakai, Y. Shimamura, and N. Morishita Int. J Pharmacol. Ther. 32 9 1994 466
4. S. Takakuwa, S. Chiku, H. Nakata, T. Yuzuriha, N. Mano, and N. Asakawa J. Chromatogr. B 673 1 1995 113
5. W.F. Keane, S.K. Swan, I. Grimes, and T.J. Humphries J. Clin. Pharmacol. 39 9 1999 927
6. S. Yasuda, S. Higashi, M. Murukami, Y. Tomono, and M. Kawaguchi Int. J. Pharmacol. Ther. 37 5 1999 249
7. H. Nakai, Y. Shimamura, T. Kanazawa, S. Yasuda, and M. Kayano J. Chromatogr. B 660 1 1994 211
8. Y. Zhang, X. Chen, Q. Gu, and D. Zhong Anal. Chim. Acta 523 2 2004 171
9. S.H. Shim, S.J. Bok, and K.I. Kwon Arch. Pharm. Res. 17 6 1994 458
10. N. Mano, Y. Oda, S. Takakuwa, S. Chiku, H. Nakata, and N. Asakawa J. Pharm. Sci. 85 9 1996 903
11. Guidance for Industry, Bioanalytical Method Validation, US Department of Health and Human Services, Food and Drug Administration Centre for Drug Evaluation and Research (CDER), Centre for veternary Medicine (CVM), May 2001 BP, website: http://www.fda.gov/cder/guidance/index.htm.
12. FDA Guidance for Industry, Biaoavaliability Studies for Orally Administered Drug: Products-General Considerations, US Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), 2000, website: http://www.fda.gov/cder/guidance/index.htm.
13. FDA Guidance for Industry, Statistical Approaches to Establishing Bioequivalence, US Department of Health and Human Services, Food and Drug Administration, Centre for Drug Evaluation and Research (CDER), 2001, website: http://www.fda.gov/cder/guidance/index.htm.