Validation of a Capillary Zone Electrophoresis Method for Determination of Rimantadine Hydrochloride in Rimantadin100 Tablets and the Method Application to Dissolution Test Monitoring

Drug Development and Industrial Pharmacy

Volumn 30, Issue 2, 2004, Pages 125-134

  Pazourek, J ^a   Revilla, A L ^a   Gajdosova D ^a   Havel, J ^a  

^a MASARYK UNIVERSITY   (Czech Republic)

Author keywords

Adamantane; Antivirotics; Capillary zone electrophoresis; Internal standard; Rimantadine; Tablets; Validation

Indexed keywords

ADAMANTANE; ANTIVIRUS AGENT; RIMANTADINE; RIMANTIDIN 100; UNCLASSIFIED DRUG;

ACCURACY; ARTICLE; CALIBRATION; CAPILLARY ZONE ELECTROPHORESIS; DRUG SOLUBILITY; DRUG STABILITY; INFLUENZA VIRUS A; STANDARD; TABLET; ULTRAVIOLET RADIATION; VALIDATION PROCESS;

ELECTROPHORESIS, CAPILLARY; NUCLEIC ACID SYNTHESIS INHIBITORS; RIMANTADINE; SOLUBILITY; TABLETS;

EID: 1842536956     PISSN: 03639045     EISSN: None     Source Type: Journal    
DOI: 10.1081/DDC-120028707     Document Type: Article

References (23)

1. Antoniadou-Vyza, E.; Avramidis, N.; Kourounakis, A.; Hadjipetrou, L. Anti-inflammatory properties of new adamantane derivatives. Design, synthesis, and biological evaluation. Arch. Pharm. Pharm. Med. Chem. 1998, 331 (2), 72-78.
2. Lin, T.; Heider, H.; Schroeder, C. Different modes of inhibition by adamantane amine derivatives and natural polyamines of the functionally reconstituted influenza virus M2 proton channel protien. J. Gen. Virol. 1997, 78, 767-774.
3. Tsunoda, A.; Maasab, H.F.; Cochran, K.W.; Eveland, W.C. Antiviral activity of alpha-methyl-1-adamantanemethylamine hydrochloride. Antimicrob. Agents Chemother. 1965, 5, 553-560.
4. Hayden, F.G.; Minocha, A.; Spyker, D.A.; Hoffman, H.E. Comparative single-dose pharmacokinetics of amantadine hydrochloride and rimantadine hydrochloride in young and elderly adults. Antimicrob. Agents Chemother. 1985, 28 (2), 216-221.
5. Altria, K.D.; Goodall, D.M.; Rogan, M.M. Quantitative applications and validation of the resolution of enantiomers by capillary electrophoresis. Electrophoresis 1994, 15 (6), 824-827.
6. Sänger-van de Griend, C.E.; Gröningsson, K. Validation of a capillary electrophoresis method for the enantiomeric purity testing of ropivacaine, a new local anaesthetic compound. J. Pharm. Biomed. Anal. 1996, 14 (3), 295-304.
7. Altria, K.D.; Walsh, A.R.; Smith, N.W. Validation of a capillary electrophoresis method for the enantiomeric purity testing of fluparoxan. J. Chromatogr. 1993, 645 (1), 193-196.
8. Altria, K.D.; Chanter, Y.L. Validation of a capillary electrophoresis method for the determination of a quinolone antibiotic and its related impurities. J. Chromatogr. 1993, 652 (2), 459-463.
9. Altria, K.D.; Filbey, S.D. Quantitative pharmaceutical analysis by capillary electrophoresis. J. Liq. Chromatogr. 1993, 16 (11), 2281-2292.
10. Liu, L.; Osborne, L.M.; Nussbaum, M.A. Development and validation of a combined potency assay and enantiomeric purity method for a chiral pharmaceutical compound using capillary electrophoresis. J. Chromatogr. 1996, 745 (1-2), 45-52.
11. Swartz, M.E.; Mazzeno, J.R.; Grover, E.R.; Brown, P.R. Validation of enantiomeric separations by micellar eletrokinetic capillary chromatography using synthetic chiral surfactants. J. Chromatogr. 1996, 735 (1-2), 303-310.
12. Thomas, B.R.; Ghodbane, S. Evaluation of a mixed micellar electrokinetic capillary electrophoresis method for validated pharmaceutical quality-control. J. Liq. Chromatogr. 1993, 16 (9-10), 1983-2006.
13. Fillet, M.; Bechet, I.; Chiap, P.; Hubert, P.; Crommen, J. Enantiomeric purity determination of propranolol by cyclodextrin-modified capillary electrophoresis. J. Chromatogr. 1995, 717 (1-2), 203-209.
14. Daali, Y.; Cherkaoui, S.; Christen, P.; Veuthey, J.-L. Experimental design for enatioselective separation of celiprolol by capillary electrophoresis using sulfated beta-cyclodextrin. Electrophoresis 1999, 20 (17), 3424-3431.
15. ICH http:/www.ifpma.org, EURACHEM http://www.vtt.fi/ket/eurachem/valid.html, http://www.vam.org.uk/.
16. Huber, L. Equipment qualification in practice. LC GC Mag. Sep. Sci. 1998, 16 (2), 148.
17. Validation of analytical methods: methodology. Pharmeuropa 1996, 8 (1).
18. Vander Heyden, Y.; Nijbuis, A.; Smeyer-Verbeke, J.; Vandeginste, B.G.M.; Massart, D.L. Guidance for robustness/ruggedness tests in method validation. http://minf.vub.ac.be/~fabi/validation/robust/guideline.doc.
19. Clarke, G.S. The validation of analytical methods for drug substances and drug products in Uk Pharmaceutical Laboratories. J. Pharm. Biomed. Anal. 1994, 12 (5), 643-652.
20. van Zoonen, P.; Hoogerbrugge, R.; Gort, S.M.; van de Wiel, H.; van't Klooster, H.A. Some practical examples of method validation in the analytical laboratory. TrAc 1999, 18 (9-10), 584-593.
21. Hubert, Ph.; Chiap, P.; Crommen, J.; Boulanger, B.; Chapuzet, E.; Mercier, N.; Bervoas-Martin, S.; Chevalier, D.; Lagorce, P.; Lallier, M.; Laparra, M.C.; Laurentie, M.; Nivet, J.C. The SFSTP guide on the validation of chromatographic methods for drug bioanalysis: from the Washington conference to the laboratory. Anal. Chim. Acta 1999, 39 (2), 135-148.
22. Revilla, A.L.; Hamáček, J.; Lubal, P.; Havel, J. Determination of rimantadine in pharmaceutical preparations by capillary zone electrophoresis with indirect detection or after derivatization. Chromatographia 1998, 47 (7-8), 433-439.
23. Reichová, N.; Pazourek, J.; Polášková, P.; Havel, J. Electrophoretic behaviour of adamantane derivatives possessing antiviral activity and their determination by capillary zone electrophoresis with indirect detection. Electrophoresis 2002, 23 (2), 259-262.