Metrika članka

  • citati u SCindeksu: 0
  • citati u CrossRef-u:0
  • citati u Google Scholaru:[=>]
  • posete u poslednjih 30 dana:35
  • preuzimanja u poslednjih 30 dana:6
članak: 1 od 1  
Back povratak na rezultate
Arhiv za farmaciju
2014, vol. 64, br. 2, str. 128-143
jezik rada: srpski
vrsta rada: izvorni naučni članak
objavljeno: 25/05/2015
doi: 10.5937/arhfarm1402128K
Plaket-Burman dizajn u proceni robusnosti metode tečne hromatografije za određivanje sadržaja natrijum-valproata
aPharma Swiss d.o.o., Beograd - Zemun
bUniverzitet u Beogradu, Farmaceutski fakultet, Institut za farmaceutsku hemiju i analitiku lekova

e-adresa: jancic.stojanovic@pharmacy.bg.ac.rs

Projekat

Modelovanje različitih hromatografskih sistema sa hemometrijskim pristupom u farmaceutskoj analizi (MPNTR - 172052)

Sažetak

U ovom radu opisana je primena Plaket-Burman dizajna u proceni robusnosti metode tečne hromatografije za određivanje sadržaja natrijum-valproata. Kao faktori koji mogu uticati na robusnost metode ispitani su sadržaj acetonitrila, koncentracija natrijum-dihidrogenfosfata, pH vrednost mobilne faze, temperatura kolone, protok mobilne faze i talasna dužina detekcije. U cilju kreiranja plana eksperimenta prema Plaket-Burman dizajnu, na 6 pravih faktora dodato je 5 veštačkih faktora i tako je ispitano 11 faktora izvođenjem 12 eksperimenata. Kao odgovori sistema praćeni su retenciono vreme, broj teorijskih platoa i simetrija pika kao kvalitativni odgovori, dok je kao kvantitativni odgovor praćena površina pika. Na osnovu dobijenih rezultata, a primenom odgovarajućih statističkih i grafičkih metoda, procenjen je uticaj ispitivanih faktora na posmatrane odgovore sistema. Pored toga, za značajne faktore određen je interval pouzdanosti tj. opseg u okviru koga se mogu menjati, a da to ne utiče značajno na odgovor sistema. Na kraju, na osnovu dobijenih rezultata, određeni su i parametri za proveru pogodnosti sistema.

Ključne reči

Plaket-Burman dizajn; robusnost; natrijum-valproat; tečna hromatografija

Reference

*** (1994) Harmonised Tripartite Guidline. u: Third International Conference on Harmonisation of Technical Requirmants for the Registration of Pharmaceuticals for Human Use (ICH), Text on Validation of Analytical Procedures, London
*** (2011) European Pharmacopoeia 7.0. Strasbourg, France: European Directorate for the Quality of Medicines & HealthCare (EDQM) - Council of Europe, Vol 1. 01
*** (2011) The United States Pharmacopeia 35, The National Formulary 30. u: United States Pharmacopoeial Convention, Rockville, MD
Ambasana, M.A., Kaila, H.O., Thakkar, R.S., Saravaia, H.T., Shah, A.K. (2011) Validation of an analytical method for assay of magnesium valproate by gas chromatography. Inter J ChemTech Res, 3: 342-47
Araujo, P.W., Brereton, R.G. (1996) Experimental design I. Screening. TrAC Trends in Analytical Chemistry, 15(1): 26-31
Armstrong, N.A. (2006) Pharmaceutical experimental design and interpretation. USA: Taylor & Francis Group
Chepkwony, H.K., Vermaelen, A., Roets, E., Hoogmartens, J. (2001) Development and validation of an reversed-phase liquid chromatographic method for analysis of spiramycin and related substances. Chromatographia, 54(1-2): 51-56
Chepkwony, H.K., Roets, E., Hoogmartens, J. (2001) Liquid chromatography of troleandomycin. Journal of chromatography. A, 914(1-2): 53-8
Dejaegher, B., Dumarey, M., Capron, X., Bloomfield, M.S., Vander, H.Y. (2007) Comparison of Plackett-Burman and supersaturated designs in robustness testing. Analytica chimica acta, 595(1-2): 59-71
Gupta, R.K., Singh, U.K., Kumar, S., Moothan, B. (2009) Estimation of sodium valproate in tablet dosage form by RP HPLC without prior derivatization: Application to dissolution studies. Int J Pharm Sci Drug Res, 1 (2), 103-06
Hund, E., Vander, H.Y., Haustein, M., Massart, D.L., Smeyers-Verbeke, J. (2000) Robustness testing of a reversed-phase high-performance liquid chromatographic assay: comparison of fractional and asymmetrical factorial designs. Journal of chromatography. A, 874(2): 167-85
Kasagić-Vujanović, I., Jovanović, M., Rakić, T., Jančić-Stojanović, B., Ivanović, D. (2012) Testiranje robusnosti metode tečne hromatografije za određivanje itrakonazola i njegovih nečistoća primenom frakcionog faktorskog dizajna. Arhiv za farmaciju, vol. 62, br. 5, str. 475-488
Lau-Cam, C.A., Roos, R.W. (1997) HPLC Method with Precolumn Phenacylation for the Assay of Valproic Acid and Its Salts in Pharmaceutical Dosage Forms. Journal of Liquid Chromatography and Related Technologies, 20(13): 2075-2087
Li, Y., Liu, H., Heyden, Y. V., Chen, M., Wang, Z., Hu, Z. (2005) Robustness tests on the United States Pharmacopoeia XXVI HPLC assay for ginsenosides in Asian and American ginseng using an experimental design. Analytica Chimica Acta, 536(1-2): 29-38
Manoj, B.M.K. (2004) Simultaneous separation and quantitation of four antiepileptic drugs--a study with potential for use in patient drug level monitoring. Journal of pharmaceutical and biomedical analysis, 34(2): 315-24
Marengoa, E., Gennaroa, M.C., Gianottia, V., Angelinoa, S. (2001) A test of robustness in IIR-RP-HPLC separation of nine pripority pollutant phenols. J Liq Chromatogr Rel Technol, 24: 341-53
Maskovic, M., Dotsikas, Y., Malenovic, A.A., Jancic-Stojanovic, B.S., Ivanovic, D.P., Medenica, M.B. (2011) Validation of an Oil-in-Water Microemulsion Liquid Chromatography Method for Analysis of Perindopril tert-Butylamine and Its Impurities. Journal of AOAC international, vol. 94, br. 3, str. 723-734
Mašković, M., Jančić-Stojanović, B., Malenović, A., Ivanović, D., Medenica, M. (2010) Assessment of liquid chromatographic method robustness by use of Plackett-Burman design. Acta Chromatographica, 22(2): 281-296
Orwa, J.A., van Gerven, A., Roets, E., Hoogmartens, J. (2000) Development and validation of a liquid chromatography method for analysis of colistin sulphate. Chromatographia, 51(7-8): 433-436
Orwa, J.A., Govaerts, C., Roets, E., van Schepdael, A., Hoogmartens, J. (2001) Liquid chromatography of gramicidin. Chromatographia, 53(1-2): 17-21
Ragonese, R., Mulholland, M., Kalman, J. (2000) 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. Journal of chromatography. A, 870(1-2): 45-51
Subasranjan, A., Suresh, P., Srinivasulu, C., Hemant, R. (2010) A validated stability-indicating gas chromatography method for determination of divalproex sodium impurities in pharmaceutical preparation. Drug testing and analysis, 2(4): 182-7
Vander, H.Y., Nijhuis, A., Smeyers-Verbeke, J., Vandeginste, B.G., Massart, D.L. (2001) Guidance for robustness/ruggedness tests in method validation. Journal of pharmaceutical and biomedical analysis, 24(5-6): 723-53
Yekkala, R.S., Vandenwayenberg, S., Hoogmartens, J., Adams, E. (2006) Evaluation of an International Pharmacopoeia method for the analysis of nelfinavir mesilate by liquid chromatography. Journal of chromatography. A, 1134(1-2): 56-65