Development and validation of gel-chromatographic and spectrophotometric methods for quantitative analysis of bioactive copper complexes in new antihypocupremical formulations

• Autorzy: Savic I , Nikolic G , Savic I , Cakic M
• Języki publikacji: EN

Abstrakty

EN

Gel-permeation chromatographic (GPC) and visible spectrophotometric methods have been developed and validated for quantitative analysis of complexes of copper(II) with the polysaccharides pullulan and dextran, active pharmaceutical compounds in new antihypocupremical formulations. Linearity, precision, accuracy, specificity, and limits of detection (LOD) and quantification (LOQ) were determined in accordance with ICH Q2(R1) guidelines. GPC was performed isocratically with redistilled water as mobile phase at a flow rate of 1 mL min ^-1 Visible spectrophotometry was performed in water, using 640 nm for direct assay of the copper(II) complex with pullulan and dextran. The calculated F and t values at the 95% confidence level were less than the theoretical values, showing there were no significant differences between the performance of the methods.

Słowa kluczowe

EN

antihypocupremical formulations; GPC; visible spectrophotometry

• Wydawca: University of Silesia in Katowice ; Akademiai Kiado
• Czasopismo: Acta Chromatographica
• Rocznik: 2010
• Tom: Vol. 22, no. 3
• Strony: 375--390
• Opis fizyczny: Bibliogr. 34 poz., rys., tab.

Twórcy

autor

Savic I

• University of Nis Department of Pharmaceutics, Faculty of Technology Bulevar Oslobodjenja 124 Leskovac 16000 Serbia

autor

Nikolic G

• University of Nis Department of Pharmaceutics, Faculty of Technology Bulevar Oslobodjenja 124 Leskovac 16000 Serbia

autor

Savic I

• University of Nis Department of Pharmaceutics, Faculty of Technology Bulevar Oslobodjenja 124 Leskovac 16000 Serbia

autor

Cakic M

• University of Nis Department of Pharmaceutics, Faculty of Technology Bulevar Oslobodjenja 124 Leskovac 16000 Serbia

Bibliografia

• [1] O. Gaiduk, R. Pantaler, N. Grebenyuk, V. Ostrovskaya, J. Anal. Chem., 64 , 216–220 (2009)
• [2] Y. Lind, A. Wicklund Glynn, BioMetals, 12 , 181–187 (1999)
• [3] M. Heidarpour Bami, M. Mohri, H. Seifi, A. Alavi Tabatabaee, Vet. Res. Commun., 32 , 553–561 (2008)
• [4] O. Sibikina, E. Novikova, A. Iozep, L. Iozep, Rus. J. Appl. Chem., 80 , 342–344 (2007)
• [5] M. Hasegawa, H. Nagae, Y. Ito, A. Mizutani, K. Hirose, M. Ohgai, Y. Yamashita, N. Tozawa, K. Yamada, K. Kito, S. Hokukoku, US Patent, 5 , 424–419, (1995)
• [6] G. Nikolić, M. Cakić, Lj. Ilić, S. Ristić, Ž. Cakić, Pharmazie, 57 , 155–158 (2002)
• [7] Lj. Ilić, S. Ristić. M. Cakić. G. Nikolić, S. Stanković, Patent WO 02/46241, (2002)
• [8] K. Burger, L. Nagy, Biocoordination Chemistry: Metal Complexes of Carbohydrates and Sugar-type Ligands, Ellis Horwood, New Jersey, 1990, pp. 236
• [9] G. Nikolić, M. Cakić, Colloid J., 69 , 464–473 (2007)
• [10] R.P. Bandwar, C.P. Rao, M. Giralt, J. Hidalgo, G.U. Kulkarni, J. Inorg. Biochem., 66 , 37–44 (1997)
• [11] G.S. Nikolić, M. Cakić, Ž. Mitić, Lj. Ilić, Complex compounds of copper(II)-ions with pullulan and its reduced and oxidized derivatives. Synthesis process, physicochemical characterization, spectra-structure correlation and pharmacological investigation of potential pharmaceutical preparation based on the complex, Serbian Patent P-0223, (2008)
• [12] Ž. Mitić, G.S. Nikolić, M. Cakić, R. Nikolić, Lj. Ilić, Russ. J. Phys. Chem., 81 , 1433–1437 (2007)
• [13] Ž. Mitić, G.S. Nikolić, M. Cakić, SPEC-2008 V International Conference of Spectroscopy, Shedding light on disease: Optical diagnosis for the New Millennium, 25–29 October 2008, Sao Paulo, Brazil (Conference Proceedings) 2008, pp. 86
• [14] Lj. Ilić, Ž. Mitić, G. Nikolić, M. Cakić, XVII Ulusal Kimya Kongresi, 8–11 Sep. Istanbul (Bildiri ozetleri Kimya), 2003, pp. 190
• [15] Ž. Mitić, M. Cakić, R. Nikolić, Lj. Ilić, G. Nikolić, J. World Polym. (Serb.), 7 , 225–229 (2004)
• [16] M. Cakić, Ž. Mitić, G.S. Nikolić, Lj. Ilić, G.M. Nikolić, Spectroscopy, 22 , 177–185 (2008)
• [17] G.S. Nikolić, M. Cakić, Ž. Mitić, Lj. Ilić, Russ. J. Coord. Chem., 34 , 322–328 (2008)
• [18] Ž. Mitić, G.S. Nikolić, M. Cakić, P. Premović, Lj. Ilić, J. Mol. Struct., 924–926 , 264–273 (2009)
• [19] Ž. Mitić, G. Nikolić, M. Cakić, R. Nikolić, Lj. Ilić, 12 th European Conference on the Spectroscopy of Biological Molecules, From molecules to tissues, 1–6 September 2007, Bobigny-Paris region, France (Book of Abstracts), 2007, pp. 319
• [20] W.F. Leech, D.G. McLaren, K.D. McSporran, Administration of copper to an animal, US Patent 0029942, 2009
• [21] Ž. Mitić, G.S. Nikolić, FIP-2008 World Congress of Pharmacy and Pharmaceutical Sciences, 68th International Congress of FIP, Reengineering Pharmacy Practice in a Changing World, 29 August–04 September 2008, Basel, Switzerland (Book of Abstracts), 2008, pp. 186
• [22] European Pharmacopoeia, Directorate for the Quality of Medicines of the Council of Europe, Strasbourg, France, fourth edn., 2004
• [23] I. Savic, G. Nikolic, I. Savic, B. Stojanovic, M. Cakic, 1st International Congress „Engineering, materials and management in the processing industry”, 14–16 October 2009, Jahorina, Republika Srpska (Proceedings CD), 2009, pp. 313–316
• [24] The European Medicines Agency Pre-Authorisation Evaluation of Medicines for Human Use . ICH Q2(R1): Validation of Analytical Procedures: Text and Methodology, EMEA/410412/2007, London, 2009
• [25] M. Swartz, I. Krull, Pharm. Technol., 22 , 104–119 (1998)
• [26] M. Varma, N. Kapoor, M. Sarkar, R. Panchagnula, J. Chromatogr. B, 813 , 347–352 (2004)
• [27] J. Ermer, J. Pharm. Biomed. Anal., 24 , 755–767 (2001)
• [28] D. Perez-Bendito, M. Silva, Kinetic Methods in Analytical Chemistry, Ellis Horwood, Chichester, 1988, p. 254
• [29] H.A. Mottola, Kinetic Aspects of Analytical Chemistry, Wiley, New York, 1988, p. 40
• [30] V. Thomsen, D. Schatzlein, D. Mercuro, Spectroscopy, 18 , 112–114 (2003)
• [31] R. Duncan, R.G. Knapp, M.C. Miller, Introductory Biostatistics for the Health Sciences, 2nd edn., Delmer Publishers, 1983, pp. 115–150
• [32] S. Bolton, Pharmaceutical Statistics: Practical and Clinical Application, 3rd edn., Marcel Dekker, New York, 1997, pp. 153, 216–269
• [33] C. Hartmann, J. Smeyers-Verbeke, W. Penninckx, Y. Heyden, P. Vankeerberghen, D. Massart, Anal. Chem., 67 , 4491–4499 (1995)
• [34] D. Skoog, D. West, F. Holler, Fundamentals of Analytical Chemistry, Saunders College Publishing, Philadelphia, 1996, p. 51