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Volumn 69, Issue , 2012, Pages 2-8

The paradigm shifting role of chromatographic methods in pharmaceutical analysis

Author keywords

GC; HPLC; Ph. Eur.; TLC; USP

Indexed keywords

MAZIPREDONE;

EID: 84865074304     PISSN: 07317085     EISSN: 1873264X     Source Type: Journal    
DOI: 10.1016/j.jpba.2012.01.031     Document Type: Review
Times cited : (17)

References (40)
  • 4
    • 84865066266 scopus 로고    scopus 로고
    • Oxford Dictionaries Online, Oxford University Press, Oxford
    • Oxford Dictionaries Online, Oxford University Press, Oxford, 2011.
    • (2011)
  • 5
    • 84865105217 scopus 로고    scopus 로고
    • ICH Guidance for Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, EMEA European Medicines Agency, London, May
    • ICH Guidance for Q6A Specifications: Test Procedures and Acceptance Criteria for New Drug Substances and New Drug Products: Chemical Substances, EMEA European Medicines Agency, London, May 2000.
    • (2000)
  • 6
    • 50649100669 scopus 로고    scopus 로고
    • Drug safety, drug quality, drug analysis
    • Görög S. Drug safety, drug quality, drug analysis. J. Pharm. Biomed. Anal. 2008, 48:247-253.
    • (2008) J. Pharm. Biomed. Anal. , vol.48 , pp. 247-253
    • Görög, S.1
  • 7
    • 84865105215 scopus 로고
    • The United States Pharmacopeia 16, The United States Pharmacopeial Convention, Washington
    • The United States Pharmacopeia 16, The United States Pharmacopeial Convention, Washington, 1960.
    • (1960)
  • 8
    • 84865065030 scopus 로고    scopus 로고
    • The United States Pharmacopeia 34, The United States Pharmacopeial Convention, Rockville
    • The United States Pharmacopeia 34, The United States Pharmacopeial Convention, Rockville, 2011.
    • (2011)
  • 9
    • 84865100483 scopus 로고    scopus 로고
    • European Pharmacopoeia 7.2, Council of Europe, Strasbourg
    • European Pharmacopoeia 7.2, Council of Europe, Strasbourg, 2011.
    • (2011)
  • 10
    • 11144288657 scopus 로고    scopus 로고
    • The sacred cow: the questionable role of assay methods in characterizing the quality of bulk pharmaceuticals
    • Görög S. The sacred cow: the questionable role of assay methods in characterizing the quality of bulk pharmaceuticals. J. Pharm. Biomed. Anal. 2005, 36:931-937.
    • (2005) J. Pharm. Biomed. Anal. , vol.36 , pp. 931-937
    • Görög, S.1
  • 11
    • 34447640143 scopus 로고    scopus 로고
    • Is HPLC assay for drug substance a useful quality control attribute?
    • Hofer J.D., Olsen B.A., Rickard E.C. Is HPLC assay for drug substance a useful quality control attribute?. J. Pharm. Biomed. Anal. 2007, 44:906-913.
    • (2007) J. Pharm. Biomed. Anal. , vol.44 , pp. 906-913
    • Hofer, J.D.1    Olsen, B.A.2    Rickard, E.C.3
  • 15
    • 84889331751 scopus 로고    scopus 로고
    • Blackwell, Oxford, R.J. Smith, M.L. Webb (Eds.)
    • Analysis of Drug Impurities 2007, Blackwell, Oxford. R.J. Smith, M.L. Webb (Eds.).
    • (2007) Analysis of Drug Impurities
  • 16
    • 33747884343 scopus 로고    scopus 로고
    • The importance and the challenges of impurity profiling in modern pharmaceutical analysis
    • Görög S. The importance and the challenges of impurity profiling in modern pharmaceutical analysis. Trends Anal. Chem. 2006, 25:755-757.
    • (2006) Trends Anal. Chem. , vol.25 , pp. 755-757
    • Görög, S.1
  • 17
    • 65349091521 scopus 로고    scopus 로고
    • Recent advances in the impurity profiling of drugs
    • Bartos D., Görög S. Recent advances in the impurity profiling of drugs. Curr. Pharm. Anal. 2008, 4:215-230.
    • (2008) Curr. Pharm. Anal. , vol.4 , pp. 215-230
    • Bartos, D.1    Görög, S.2
  • 20
    • 33747892634 scopus 로고    scopus 로고
    • Informa Healthcare, London, S.W. Baertschi, K.M. Alsante, R.A. Reed (Eds.)
    • Pharmaceutical Stress Testing: Predicting Drug Degradation 2011, Informa Healthcare, London. S.W. Baertschi, K.M. Alsante, R.A. Reed (Eds.).
    • (2011) Pharmaceutical Stress Testing: Predicting Drug Degradation
  • 21
    • 33845948858 scopus 로고    scopus 로고
    • The changing face of pharmaceutical analysis
    • Görög S. The changing face of pharmaceutical analysis. Trends Anal. Chem. 2007, 26:12-17.
    • (2007) Trends Anal. Chem. , vol.26 , pp. 12-17
    • Görög, S.1
  • 23
    • 79954630133 scopus 로고    scopus 로고
    • Impurity profiling of pharmaceuticals by thin-layer chromatography
    • Ferenczi-Fodor K., Végh Z., Renger B. Impurity profiling of pharmaceuticals by thin-layer chromatography. J. Chromatogr. A 2011, 1218:2722-2731.
    • (2011) J. Chromatogr. A , vol.1218 , pp. 2722-2731
    • Ferenczi-Fodor, K.1    Végh, Z.2    Renger, B.3
  • 24
    • 75949096893 scopus 로고    scopus 로고
    • Performance of columns packed with the new shell Kinetex-C18 particles in gradient elution chromatography
    • Gritti F., Guiochon G. Performance of columns packed with the new shell Kinetex-C18 particles in gradient elution chromatography. J. Chromatogr. A 2010, 1217:1604-1615.
    • (2010) J. Chromatogr. A , vol.1217 , pp. 1604-1615
    • Gritti, F.1    Guiochon, G.2
  • 25
    • 77952672825 scopus 로고    scopus 로고
    • Comparative study of new shell-type, sub-2μm fully porous and monolith stationary phases, focusing on mass-transfer resistance
    • Oláh E., Fekete S., Fekete J., Ganzler K. Comparative study of new shell-type, sub-2μm fully porous and monolith stationary phases, focusing on mass-transfer resistance. J. Chromatogr. A 2010, 1217:3642-3653.
    • (2010) J. Chromatogr. A , vol.1217 , pp. 3642-3653
    • Oláh, E.1    Fekete, S.2    Fekete, J.3    Ganzler, K.4
  • 26
    • 79952817768 scopus 로고    scopus 로고
    • Shell particles, trials, tibilations and triumphs
    • Guiochon G., Gritti F. Shell particles, trials, tibilations and triumphs. J. Chromatogr. A 2011, 1218:1915-1935.
    • (2011) J. Chromatogr. A , vol.1218 , pp. 1915-1935
    • Guiochon, G.1    Gritti, F.2
  • 27
    • 79952317047 scopus 로고    scopus 로고
    • Fast gradient screening of pharmaceuticals with 5cm long, narrow bore reversed-phase columns packed with sub-3μm core-shell and sub-2μm totally porous particles
    • Fekete S., Fekete J. Fast gradient screening of pharmaceuticals with 5cm long, narrow bore reversed-phase columns packed with sub-3μm core-shell and sub-2μm totally porous particles. Talanta 2011, 84:416-423.
    • (2011) Talanta , vol.84 , pp. 416-423
    • Fekete, S.1    Fekete, J.2
  • 28
    • 33747877146 scopus 로고    scopus 로고
    • Advances in HPLC technology for the determination of drug impurities
    • Olsen B.A., Castle B.C., Myers D.P. Advances in HPLC technology for the determination of drug impurities. Trends. Anal. Chem. 2006, 25:796-805.
    • (2006) Trends. Anal. Chem. , vol.25 , pp. 796-805
    • Olsen, B.A.1    Castle, B.C.2    Myers, D.P.3
  • 35
    • 85128551035 scopus 로고    scopus 로고
    • CRC Press, Boca Raton, A. Van Eeckhaut, Y. Michotte (Eds.)
    • Chiral Separations by Capillary Electrophoresis 2009, CRC Press, Boca Raton. A. Van Eeckhaut, Y. Michotte (Eds.).
    • (2009) Chiral Separations by Capillary Electrophoresis
  • 36
    • 36949083820 scopus 로고
    • Amino derivatives of 11β, 17β, 21-trihydroxy-3,20-dioxo- 1,4-pregnadiene
    • Tóth J., Tuba Z., Szporny L. Amino derivatives of 11β, 17β, 21-trihydroxy-3,20-dioxo- 1,4-pregnadiene. Nature 1961, 191:607.
    • (1961) Nature , vol.191 , pp. 607
    • Tóth, J.1    Tuba, Z.2    Szporny, L.3
  • 37
    • 0013878777 scopus 로고
    • Depersolone (11β, 17β-dihydroxy-3,20 dioxo-21-N(N'-methylpiperazinyl)-1,4-pregnadiene hydrochloride) a new watersoluble glucocorticoid
    • Szporny L., Dömök L., Görög P., Fekete G. Depersolone (11β, 17β-dihydroxy-3,20 dioxo-21-N(N'-methylpiperazinyl)-1,4-pregnadiene hydrochloride) a new watersoluble glucocorticoid. Steroids 1966, 7:181-193.
    • (1966) Steroids , vol.7 , pp. 181-193
    • Szporny, L.1    Dömök, L.2    Görög, P.3    Fekete, G.4
  • 38
    • 0014599714 scopus 로고
    • Determination of 21-amino corticosteroids
    • Görög S., Tuba Z., Egyed I. Determination of 21-amino corticosteroids. Analyst 1969, 94:1044-1046.
    • (1969) Analyst , vol.94 , pp. 1044-1046
    • Görög, S.1    Tuba, Z.2    Egyed, I.3
  • 39
    • 0032409409 scopus 로고    scopus 로고
    • Estimation of impurity profiles of drugs and related materials. Part 18. Impurities and degradation products of mazipredone
    • Gazdag M., Babják M., Mahó S., Tuba Z., Görög S. Estimation of impurity profiles of drugs and related materials. Part 18. Impurities and degradation products of mazipredone. J. Pharm. Biomed. Anal. 1998, 17:1029-1036.
    • (1998) J. Pharm. Biomed. Anal. , vol.17 , pp. 1029-1036
    • Gazdag, M.1    Babják, M.2    Mahó, S.3    Tuba, Z.4    Görög, S.5
  • 40
    • 3042602402 scopus 로고    scopus 로고
    • New safe medicines faster: the role of analytical chemistry
    • Görög S. New safe medicines faster: the role of analytical chemistry. Trends Anal Chem. 2003, 22:407-415.
    • (2003) Trends Anal Chem. , vol.22 , pp. 407-415
    • Görög, S.1


* 이 정보는 Elsevier사의 SCOPUS DB에서 KISTI가 분석하여 추출한 것입니다.