Development and validation of a stability-indicating LC method for the determination of venlafaxine in extended-release capsules and dissolution kinetic studies

Journal of Chromatographic Science

Volumn 47, Issue 9, 2009, Pages 770-776

  Bernardi, Larissa S ^a   Oliveira, Paulo R ^a   Murakami, Fábio S ^a   Borgmann, Silvia H M ^a   Arend, Marcela Z ^b   Cardoso, Simone G ^a  

^a FEDERAL UNIVERSITY OF SANTA CATARINA   (Brazil)

^b FEDERAL UNIVERSITY OF SANTA MARIA   (Brazil)

Author keywords

[No Author keywords available]

Indexed keywords

EID: 70449338445     PISSN: 00219665     EISSN: None     Source Type: Journal    
DOI: 10.1093/chromsci/47.9.770     Document Type: Article

References (33)

1. M. Rudorfer and W. Potter. Antidepressants: a comparative review of the clinical pharmacology and therapeutic use of the "newer" versus the "older" drugs. Drugs. 37: 713-738 (1989).
2. J.M. Andrews, P.T. Ninan, and C.B. Nemeroff. Venlafaxine: a novel antidepressant that has a dual mechanism of action. Depression. 4: 48-56 (1996).
3. M.A. Gutierrez, G.L. Stimmel, and J.Y. Aiso. Venlafaxine: A 2003 Update. Clin. Ther. 25: 2138-2154 (2003).
4. Effexor XR (venlafaxine hydrochloride) extended release capsules. (2008) Available at: http://www.wyeth.com/content/showlabeling.asp?id=100.
5. N.R. Trivedi, M.G. Rajan, J.R. Johnson, and A.J. Shukla. Pharmaceutical Approaches to preparing pelletized dosage forms using the extrusion-spheronization process. Crit. Rev. Ther Drug. 24: 1-40 (2007).
6. I. Ghebre-Sellanie. Multiparticulate oral drug delivery. Marcel Dekker Inc. New York. 1994.
7. M.S. Kim, J.S. Kim, Y.H. You, H. J. Park, S. Lee, J.S. Park, J.S. Woo, and S.J Hwang. Development and optimization of a novel oral controlled delivery system for tamsulosin hydrochloride using response surface methodology. Int. J. Pharm. 341: 97-104 (2007).
8. K.M. Alsante, A. Ando, R. Brown, J. Ensing, T.D. Hatajik, W. Kong, and Y. Tsuda. The role of degradant profiling in active pharmaceutical ingredients and drug products. Adv. Drug Deliver. Rev. 59: 29-37 (2007).
9. M. Bakshi and S. Singh. Development of validated stability-indicating assay methods - critical review. J. Pharm Biomed. Anal. 28: 1011-1040 (2002).
10. R.N. Rao and V. Nagaraju. An overview of the recent trends in development of HPLC methods for determination of impurities in drugs. J. Pharm Biomed. Anal. 33: 335-377 (2003).
11. S. Rudaz, C. Stella, A.E. Balant-Gorgia, S. Fanali, and J.L. Veuthey. Simultaneous stereoselective analysis of venlafaxine and O-desmethylvenlafaxine enantiomers in clinical samples by capillary electrophoresis using charged cyclodextrins. J. Pharm. Biomed. Anal. 23: 107-115 (2000).
12. S. Rudaz, J.L. Veuthey, C. Desiderio, and S. Fanali. Enantioseparation of Venlafaxine and O-Desmethylven-lafaxine by Capillary Electrophoresis with Mixed Cyclodextrins. Chromatographia. 50: 369-372 (1999).
13. R.L. Vu, D. Helmeste, L. Albers, and C. Reist. Rapid determination of venlafaxine and O-desmethylvenlafaxine in human plasma by high-performance liquid chromatography with fluorimetric detection. J. Chromatogr. B 703: 195-201 (1997).
14. J. Bhatt, A. Jangid, G. Venkatesh, G. Subbaiah, and S. Singh. Liquid chromatography-tandem mass spectrometry (LC-MS-MS) method for simultaneous determination of venlafaxine and its active metabolite O-desmethylvenlafaxine in human plasma J. Chromatogr. B 829: 75-81 (2005).
15. W. Liu, H. Cai, and H. Li. High performance liquid chromatography-electrospray ionization mass spectrometry (HPLC-MS/ESI) method for simultaneous determination of venlafaxine and its three metabolites in human plasma. J. Chromatogr. B 850: 405-411 (2007).
16. W. Liu, H. Cai, and F. Wang. Simultaneous stereoselective analysis of venlafaxine and O-desmethylvenlafaxine enantiomers in human plasma by HPLC-ESI/MS using a vancomycin chiral column. J. Chromatogr. B 850: 183-189 (2007).
17. S.N. Makhija and P.R. Vavia. Stability indicating LC method for the estimation of venlafaxine in pharmaceutical formulations. J. Pharm. Biomed. Anal. 28: 1055-1059 (2002).
18. R.N. Rao and A.N. Raju. Simultaneous separation and determination of process-related substances and degradation products of venlafaxine by reversed-phase HPLC. J. Sep. Sci. 29: 2733-2744 (2006).
19. E.B. Asafu-Adjaye, P.J. Faustino, M.A. Tawakkul, L.W. Anderson, L.X. Yu, W. Know, and D.A. Volpe. Validation and application of a stability-indicating HPLC method for the in vitro determination of gastric and intestinal stability of venlafaxine. J. Pharm. Biomed. Anal. 43: 1854-1859 (2007).
20. S. Furlanetto, F. Maestrelli, S. Orlandini, S. Pinzauti, and P. Mura. Optimization of dissolution test precision for a Ketoprofen oral extend-release product. J. Pharm. Biomed. Anal. 32: 159-162 (2003).
21. FDA 1997, Center for drug evaluation and research, Guidance for Industry: Dissolution testing of immediate release solid oral dosage forms, August 1997.
22. United States Pharmacopeia (USP 32), United Pharma-copeial Convention Inc., Rockville, USA, 2008.
23. S. Azarmi, W. Roa, and R. Löbenberg. Current perspectives in dissolution testing of conventional and novel dosage forms. Int. J. Pharm. 328: 12-21 (2007).
24. U.V. Banakar. Pharmaceutical dissolution testing. 1st ed, Marcel Dekker Inc., New York, 1992.
25. International Conference on Harmonisation (ICH), Harmonised tripartite guideline: validation of analytical procedures: text and methodology Q2 (R1) (2005).
26. B. Dejaegher and Y.V. Heyden. Ruggedness and robustness testing. J. Chromatogr. A 1158: 138-157 (2007).
27. Y.V. Heyden, A. Nijhuis, J. Smeyers-Verbeke, B.G.M. Vandeginste, and D.L. Massart. Guidance for robustness/ruggedness test in method validation. J. Pharm. Biomed. Anal. 24: 723-753 (2001).
28. R. Ragonese, M. Mulholland, and J. Kalman. Full and fractionated experimental designs for robustness testing in the high-performance liquid chromatographic analysis of codeine phosphate, pseudoephedrine hydrochloride and chlorpheniramine maleate in a pharmaceutical preparation. J. Chromatogr. A 870: 45-51 (2000).
29. K.A. Khan and C.T. Rhodes. Concept of dissolution efficiency. J. Pharm. Pharmacol. London. 27: 48-49 (1975).
30. P. Costa and J.M.S. Lobo. Modeling and comparison of dissolution profiles. Eur. J. Pharm. Sci. 13: 123-133 (2001).
31. R. Manadas, M.E. Pina, and F. Veiga. A dissolução in vitro na previsão da absorção oral de fármacos em formas farmacêuticas de liberação modificada. Braz. J. Pharm. Sci. 38: 375-399 (2002).
32. J.B. Dressman, G.L. Amidon, C. Reppas, and V.P. Shah. Dissolution testing as a prognostic tool for oral drug absorption: immediate release dosage forms. Pharm. Res. 15: 11-22 (1998).
33. E.D. Jorgensen and D. Bhagwat. Development of dissolution tests for oral extended-release products. Pharm. Sci. Technol. Today. 1: 128-135 (1998).