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Czasopismo
2011 | 9 | 3 | 446-452
Tytuł artykułu

Development and validation of an ultra-fast liquid chromatographic method for the quality control of famotidine formulations using a short monolithic stationary phase

Treść / Zawartość
Warianty tytułu
Języki publikacji
EN
Abstrakty
EN
An HPLC method for the quality control of famotidine (FMT) containing formulations has been developed and validated. The combination of a short monolithic column (Chromolith® RP-18e 50 × 4.6 mm i.d.) and an elevated flow rate (3.0 mL min−1) enabled the proposal of a high-throughput analytical scheme capable of reliable operation in a demanding industrial environment. Detection was carried out at 265 nm. Thorough validation of the method included linearity (5–150%), limits of detection (0.13%) and quantification (0.41%), selectivity, precision (within- and day-to-day), accuracy and ruggedness. The new method was applied successfully to the analysis of samples (assay, dissolution, dosage & blending uniformity) during the production of four validation batches of FMT-containing tablets.
Wydawca

Czasopismo
Rocznik
Tom
9
Numer
3
Strony
446-452
Opis fizyczny
Daty
wydano
2011-06-01
online
2011-03-22
Twórcy
Bibliografia
  • [1] T. J. Humphries, Scand. J. Gastroenterol. 22, 55 (1987) http://dx.doi.org/10.3109/00365528709090142[Crossref]
  • [2] B. Simon, P. Muller, H.G. Dammann, Innere Medizin 11, 81 (1984)
  • [3] T.J. Humphries and G.J. Merritt, Aliment. Pharmacol. Ther. 13, 18 (1999) http://dx.doi.org/10.1046/j.1365-2036.1999.00021.x[Crossref]
  • [4] P.D. Tzanavaras, D.G. Themelis, Anal. Chim. Acta 588, 1 (2007) http://dx.doi.org/10.1016/j.aca.2007.01.060[Crossref]
  • [5] D. Guillarme, D.T.T. Nguyen, S. Rudaz, J-L. Veuthey, Eur. J. Pharm. Biopharm. 68, 430 (2008) http://dx.doi.org/10.1016/j.ejpb.2007.06.018[Crossref]
  • [6] M.E. Swartz, J. Liq. Chromatogr. Relat. Technol. 28, 1253 (2005) http://dx.doi.org/10.1081/JLC-200053046[Crossref]
  • [7] M.W. Dong, LC-GC North America 25, 656 (2007)
  • [8] K. Cabrera, D. Lubda, H-M. Eggenweiler, H. Minakuchi, K. Nakanishi, J. High Resolut. Chromatogr. 23, 93 (2000) http://dx.doi.org/10.1002/(SICI)1521-4168(20000101)23:1<93::AID-JHRC93>3.0.CO;2-2[Crossref]
  • [9] C.K. Zacharis, J. Chromatogr. Sci. 47, 443 (2009)
  • [10] R. Isono, H. Kurokawa, N. Suzaki, M. Tomida, S. Kadil, T. Yamaguchi, Y. Fujita, Bunseki Kagaku 58, 715 (2009) http://dx.doi.org/10.2116/bunsekikagaku.58.715[Crossref]
  • [11] M.I. Walash, A. El-Brashy, N. El-Enany, M.E. Kamel, J. Fruoresc. 19, 333 (2009) http://dx.doi.org/10.1007/s10895-008-0421-3[Crossref]
  • [12] I.A. Darwish, S.A. Hussein, A.M. Mahmoud, A.I. Hassan, Spectrochim. Acta A 69, 33 (2008) http://dx.doi.org/10.1016/j.saa.2007.03.005[Crossref]
  • [13] M.I. Walash, M.K. Sharaf-El-Din, M. El-Sayed Metwally, M.R. Shabana, J. Chin. Chem. Soc. (Taipei) 52, 71 (2005)
  • [14] Z. Korićanac T. Jovanović, J. Petković, D. Minić, J. Serb. Chem. Soc. 69, 485 (2004) http://dx.doi.org/10.2298/JSC0406485K[Crossref]
  • [15] M.S. Elazazy, A. Shalaby, M.N. Elbolkiny, H.M. Khalil, Chin. Pharm. J. 55, 481 (2003)
  • [16] M.M. Ayad, A. Shalaby, H.E. Abdellatef, M.M. Hosny, Anal. Bioanal. Chem. 376, 710 (2003) http://dx.doi.org/10.1007/s00216-003-1954-6[Crossref]
  • [17] N. Rahman, M. Kashif, Anal. Sci. 19, 907 (2003) http://dx.doi.org/10.2116/analsci.19.907[Crossref]
  • [18] N. Helali, N.T. Tran, L. Monser, M. Taverna, Talanta 74, 694 (2008) http://dx.doi.org/10.1016/j.talanta.2007.06.036[Crossref]
  • [19] T. Perez-Ruiz, C. Martinez-Lozano, V. Tomas, E. Bravo, R. Galera, J. Pharm. Biomed. Anal. 30, 1055 (2002) http://dx.doi.org/10.1016/S0731-7085(02)00444-2[Crossref]
  • [20] N. Helali, L. Monser, J. Sep. Sci. 31, 276 (2008) http://dx.doi.org/10.1002/jssc.200700347[Crossref]
  • [21] N. Helali, F. Darghouth, L. Monser, Chromatographia 60, 455 (2004) http://dx.doi.org/10.1365/s10337-004-0386-6[Crossref]
  • [22] C. Ho, H-M. Huang, S-Y. Hsu, C-Y. Shaw, B-L. Chang, Drug Dev. Ind. Pharm. 25, 379 (1999) http://dx.doi.org/10.1081/DDC-100102186[Crossref]
  • [23] A. Zarghi, A. Shafaati, S.M. Foroutan, A. Khoddam, J. Pharm. Biomed. Anal. 39, 677 (2005) http://dx.doi.org/10.1016/j.jpba.2005.03.029[Crossref]
  • [24] United States Pharmacopoeia, USP30-NF25 2112 (2007)
  • [25] S.L. Rivera, S. Ghodbane, Int. J. Pharm. 108, 31 (1994) http://dx.doi.org/10.1016/0378-5173(94)90413-8[Crossref]
  • [26] S. Wanwimolruk, A.R. Zoest, S.Z. Wanwimolruk, C.T. Hung, J. Chromatogr. B 572, 227 (1991) http://dx.doi.org/10.1016/0378-4347(91)80487-W[Crossref]
  • [27] P.D. Tzanavaras, D.G. Themelis, Anal. Chim. Acta 581, 89 (2007) http://dx.doi.org/10.1016/j.aca.2006.07.081[Crossref]
  • [28] Food and Drug Administration: Guidance for Industry. Dissolution Testing of Immediate Release Solid Oral Dosage Forms (US Department of Health and Human Services/Food and Drug Administration/Center for Drug Evaluation and Research, Rockville MD, 1997)
Typ dokumentu
Bibliografia
Identyfikatory
Identyfikator YADDA
bwmeta1.element.-psjd-doi-10_2478_s11532-011-0022-x
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