Analytical quality by design in the development of a cyclodextrin-modified capillary electrophoresis method for the assay of metformin and its related substances (213 views)
Electrophoresis (ISSN: 0173-0835), 2014; 35(17): 2538-2545.
Export to BibTeX Export to EndNote
Paper type: Journal Article,
Impact factor: 3.028, 5-year impact factor: 2.723
Url: https://www.scopus.com/inward/record.uri?eid=2-s2.0-84906937612&doi=10.1002%2felps.201400173&partnerID=40&md5=beedd950f33267ac68f82fe60793d111
Keywords: Capillary Electrophoresis, Experimental Design, Impurities, Metformin, Quality By Design, 6 Diamino 1, 5 Triazin 2 Yl)guanidine, 1 Methylbiguanide, 1 Dimethylbiguanide Hydrochloride, Carboxymethyl Beta Cyclodextrin, Dicyanodiamide, Melamine 1, 5 Triazine 2, 6 Triamine, N Dimethyl 1, Unclassified Drug, Tablet, Analytic Method, Analytical Parameters, Article, Chemometric Analysis, Control Strategy, Drug Impurity, Monte Carlo Method, Probability, Quality Control Procedures, Response Surface Method, Risk Assessment, Controlled Study, Drug Determination, Drug Structure, Measurement Accuracy, Measurement Precision, Analogs And Derivatives, Chemistry, Drug Contamination, Methodology, Reproducibility, Reproducibility Of Results, Research Design,
Affiliations:
*** IBB - CNR ***
Department of Chemistry U. Schiff, University of Florence, Sesto Fiorentino, Florence, Italy
Department of Pharmacy and Biotechnology, University of Bologna, Bologna, Italy
Institute of Biostructure and Bioimaging, National Research Council (CNR), Catania, Italy
Department of Experimental and Clinical Medicine, Florence, Italy
References:
Sweetman, S.C., (2005) Martindale: The Complete Drug Reference, pp. 342-343. , (Ed.), 34th edition, Pharmaceutical Press, Londo
(2010) European Pharmacopoeia 7.0, 2, pp. 2458-2459. , Council of Europe, Strasbourg
David, V., Medvedovici, A., Albu, F., (2005) J. Liq. Chromatogr. R. T., 28, pp. 81-95
Raghava Raju, T.V., Jagan Mohan, T.S.S., Bhavani Prasad, S.V.S.G., Suresh Kumar, P., Someswara Rao, N., Mrutyunjaya Rao, I., (2013) Asian J. Pharm. Clin. Res., 6, pp. 107-115
Ali, M.S., Rafiuddin, S., Ghori, M., Khatri, A.R., (2008) Chromatographia, 67, pp. 517-525
Al-Rimawi, F., (2009) Talanta, 79, pp. 1368-1371
Kłaczkow, G., Anuszewska, E.L., (2010) Acta Pol. Pharm.-Drug Res., 67, pp. 593-598
Thomas, A.B., Patil, S.D., Nanda, R.K., Kothapalli, L.P., Bhosle, S.S., Deshpande, A.D., (2011) Saudi Pharm. J., 19, pp. 221-231
Joshi, S.S., Nahire, R.R., Shastri, N.R., Surendranath, K.V., Satish, J., (2012) Acta Chromatogr., 24, pp. 419-432
Peraman, R., Gowra, C.S., Reddy, Y.P., Peruru, K.K., (2013) Chromatographia, 76, pp. 1153-1162
Malleswararao, C.S.N., Suryanarayana, M.V., Mukkanti, K., (2012) Sci. Pharm., 80, pp. 139-152
Ali, I., Aboul-Enein, H.Y., Gupta, V.K., (2007) Comb. Chem. High T. Scr., 10, pp. 611-615
Zhai, H.Y., Wu, Y., Huang, B., Huang, Q., Yang, B., Chen, Z., (2008) Chem. Res. Appl., 20, pp. 923-926
Barden, A.T., Lopes Piccoli, B., Volpato, N.M., Steppe, M., (2013) Anal. Methods, 5, pp. 5701-5708
Salim, M., El-Enany, N., Belal, F., Walash, M., Patonay, G., (2012) Anal. Chem. Ins., 7, pp. 31-46
Yardimci, C., Özaltin, N., (2005) Anal. Chim. Acta, 549, pp. 88-95
Hamdan, I.I., Bani Jaber, A.K., Abushoffa, A.M., (2010) J. Pharm. Biomed. Anal., 53, pp. 1254-1257
(2009), ICH Harmonised Tripartite Guideline, Q8(R2), Pharmaceutical Development
Orlandini, S., Pinzauti, S., Furlanetto, S., (2013) Anal. Bioanal. Chem., 405, pp. 443-450
Rozet, E., Lebrun, P., Debrus, B., Boulanger, B., Hubert, P., (2013) Trends Anal. Chem., 42, pp. 157-167
Debrus, B., Guillarme, D., Rudaz, S., (2013) J. Pharm. Biomed. Anal., 84, pp. 215-223
Dispas, A., Lebrun, P., Andri, B., Rozet, E., Hubert, P., (2014) J. Pharm. Biomed. Anal., 88, pp. 519-524
Hubert, C., Lebrun, P., Houari, S., Ziemons, E., Rozet, E., Hubert, P., (2014) J. Pharm. Biomed. Anal., 88, pp. 401-409
Monks, K., Molnár, I., Rieger, H.-J., Bogáti, B., Szabó, E., (2012) J. Chromatogr. A, 1232, pp. 218-230
Schmidt, A.H., Stanic, M., Molnár, I., (2014) J. Pharm. Biomed. Anal., 91, pp. 97-107
Piepel, G., Pasquini, B., Cooley, S., Heredia-Langner, A., Orlandini, S., Furlanetto, S., (2012) Talanta, 97, pp. 73-82
Orlandini, S., Pasquini, B., Stocchero, M., Pinzauti, S., Furlanetto, S., (2014) J. Chromatogr. A, 1339, pp. 200-209
Furlanetto, S., Orlandini, S., Pasquini, B., Del Bubba, M., Pinzauti, S., (2013) Anal. Chim. Acta, 802, pp. 113-124
Michels, D.A., Parker, M., Salas-Solano, O., (2012) Electrophoresis, 33, pp. 815-826
El Deeb, S., Wätzig, H., El-Hady, D.A., Albishri, H.M., Sänger-van de Griend, C., Scriba, G.K.E., (2014) Electrophoresis, 35, pp. 170-189
Orlandini, S., Gotti, R., Furlanetto, S., (2014) J. Pharm. Biomed. Anal., 87, pp. 290-307
Lewis, G., Mathieu, D., Phan-Tan-Luu, R., (1999) Pharmaceutical Experimental Design, , Marcel Dekker, New York
Herrador, M.A., Asuero, A.G., Gonzalez, A.G., (2005) Chemom. Intell. Lab. Syst., 79, pp. 115-122
(2005), ICH Harmonised Tripartite Guideline, Q2(R1), Validation of Analytical Procedures: Text and Methodology
Mathieu, D., Nony, J., Phan-Tan-Luu, R., NEMROD-W, LPRAI sarl, Marseille
MODDE v. 10, MKS Umetrics AB, Sweden
Orlandini, S., Giannini, I., Gotti, R., Pinzauti, S., La Porta, S., Furlanetto, S., (2007) Electrophoresis, 28, pp. 395-405
Ishikawa, K., (1985) What is Total Quality Control? The Japanese Way, , Prentice-Hall, Englewood Cliffs
Furlanetto, S., Pinzauti, S., La Porta, E., Chiarugi, A., Mura, P., Orlandini, S., (1998) J. Pharm. Biomed. Anal., 17, pp. 1015-1028
Pieraccini, G., Furlanetto, S., Orlandini, S., Bartolucci, G., Giannini, I., Pinzauti, S., Moneti, G., (2008) J. Chromatogr. A, 1180, pp. 138-150
Ermer, J., Miller, J.H., (2004) Method Validation in Pharmaceutical Analysis-A Guide to Best Practice, , McB. (Eds.), Wiley-VCH, Weinheim
Electrophoresis (ISSN: 0173-0835), 2014; 35(17): 2538-2545.
Export to BibTeX Export to EndNote
Paper type: Journal Article,
Impact factor: 3.028, 5-year impact factor: 2.723
Url: https://www.scopus.com/inward/record.uri?eid=2-s2.0-84906937612&doi=10.1002%2felps.201400173&partnerID=40&md5=beedd950f33267ac68f82fe60793d111
Keywords: Capillary Electrophoresis, Experimental Design, Impurities, Metformin, Quality By Design, 6 Diamino 1, 5 Triazin 2 Yl)guanidine, 1 Methylbiguanide, 1 Dimethylbiguanide Hydrochloride, Carboxymethyl Beta Cyclodextrin, Dicyanodiamide, Melamine 1, 5 Triazine 2, 6 Triamine, N Dimethyl 1, Unclassified Drug, Tablet, Analytic Method, Analytical Parameters, Article, Chemometric Analysis, Control Strategy, Drug Impurity, Monte Carlo Method, Probability, Quality Control Procedures, Response Surface Method, Risk Assessment, Controlled Study, Drug Determination, Drug Structure, Measurement Accuracy, Measurement Precision, Analogs And Derivatives, Chemistry, Drug Contamination, Methodology, Reproducibility, Reproducibility Of Results, Research Design,
Affiliations:
*** IBB - CNR ***
Department of Chemistry U. Schiff, University of Florence, Sesto Fiorentino, Florence, Italy
Department of Pharmacy and Biotechnology, University of Bologna, Bologna, Italy
Institute of Biostructure and Bioimaging, National Research Council (CNR), Catania, Italy
Department of Experimental and Clinical Medicine, Florence, Italy
References:
Sweetman, S.C., (2005) Martindale: The Complete Drug Reference, pp. 342-343. , (Ed.), 34th edition, Pharmaceutical Press, Londo
(2010) European Pharmacopoeia 7.0, 2, pp. 2458-2459. , Council of Europe, Strasbourg
David, V., Medvedovici, A., Albu, F., (2005) J. Liq. Chromatogr. R. T., 28, pp. 81-95
Raghava Raju, T.V., Jagan Mohan, T.S.S., Bhavani Prasad, S.V.S.G., Suresh Kumar, P., Someswara Rao, N., Mrutyunjaya Rao, I., (2013) Asian J. Pharm. Clin. Res., 6, pp. 107-115
Ali, M.S., Rafiuddin, S., Ghori, M., Khatri, A.R., (2008) Chromatographia, 67, pp. 517-525
Al-Rimawi, F., (2009) Talanta, 79, pp. 1368-1371
Kłaczkow, G., Anuszewska, E.L., (2010) Acta Pol. Pharm.-Drug Res., 67, pp. 593-598
Thomas, A.B., Patil, S.D., Nanda, R.K., Kothapalli, L.P., Bhosle, S.S., Deshpande, A.D., (2011) Saudi Pharm. J., 19, pp. 221-231
Joshi, S.S., Nahire, R.R., Shastri, N.R., Surendranath, K.V., Satish, J., (2012) Acta Chromatogr., 24, pp. 419-432
Peraman, R., Gowra, C.S., Reddy, Y.P., Peruru, K.K., (2013) Chromatographia, 76, pp. 1153-1162
Malleswararao, C.S.N., Suryanarayana, M.V., Mukkanti, K., (2012) Sci. Pharm., 80, pp. 139-152
Ali, I., Aboul-Enein, H.Y., Gupta, V.K., (2007) Comb. Chem. High T. Scr., 10, pp. 611-615
Zhai, H.Y., Wu, Y., Huang, B., Huang, Q., Yang, B., Chen, Z., (2008) Chem. Res. Appl., 20, pp. 923-926
Barden, A.T., Lopes Piccoli, B., Volpato, N.M., Steppe, M., (2013) Anal. Methods, 5, pp. 5701-5708
Salim, M., El-Enany, N., Belal, F., Walash, M., Patonay, G., (2012) Anal. Chem. Ins., 7, pp. 31-46
Yardimci, C., Özaltin, N., (2005) Anal. Chim. Acta, 549, pp. 88-95
Hamdan, I.I., Bani Jaber, A.K., Abushoffa, A.M., (2010) J. Pharm. Biomed. Anal., 53, pp. 1254-1257
(2009), ICH Harmonised Tripartite Guideline, Q8(R2), Pharmaceutical Development
Orlandini, S., Pinzauti, S., Furlanetto, S., (2013) Anal. Bioanal. Chem., 405, pp. 443-450
Rozet, E., Lebrun, P., Debrus, B., Boulanger, B., Hubert, P., (2013) Trends Anal. Chem., 42, pp. 157-167
Debrus, B., Guillarme, D., Rudaz, S., (2013) J. Pharm. Biomed. Anal., 84, pp. 215-223
Dispas, A., Lebrun, P., Andri, B., Rozet, E., Hubert, P., (2014) J. Pharm. Biomed. Anal., 88, pp. 519-524
Hubert, C., Lebrun, P., Houari, S., Ziemons, E., Rozet, E., Hubert, P., (2014) J. Pharm. Biomed. Anal., 88, pp. 401-409
Monks, K., Molnár, I., Rieger, H.-J., Bogáti, B., Szabó, E., (2012) J. Chromatogr. A, 1232, pp. 218-230
Schmidt, A.H., Stanic, M., Molnár, I., (2014) J. Pharm. Biomed. Anal., 91, pp. 97-107
Piepel, G., Pasquini, B., Cooley, S., Heredia-Langner, A., Orlandini, S., Furlanetto, S., (2012) Talanta, 97, pp. 73-82
Orlandini, S., Pasquini, B., Stocchero, M., Pinzauti, S., Furlanetto, S., (2014) J. Chromatogr. A, 1339, pp. 200-209
Furlanetto, S., Orlandini, S., Pasquini, B., Del Bubba, M., Pinzauti, S., (2013) Anal. Chim. Acta, 802, pp. 113-124
Michels, D.A., Parker, M., Salas-Solano, O., (2012) Electrophoresis, 33, pp. 815-826
El Deeb, S., Wätzig, H., El-Hady, D.A., Albishri, H.M., Sänger-van de Griend, C., Scriba, G.K.E., (2014) Electrophoresis, 35, pp. 170-189
Orlandini, S., Gotti, R., Furlanetto, S., (2014) J. Pharm. Biomed. Anal., 87, pp. 290-307
Lewis, G., Mathieu, D., Phan-Tan-Luu, R., (1999) Pharmaceutical Experimental Design, , Marcel Dekker, New York
Herrador, M.A., Asuero, A.G., Gonzalez, A.G., (2005) Chemom. Intell. Lab. Syst., 79, pp. 115-122
(2005), ICH Harmonised Tripartite Guideline, Q2(R1), Validation of Analytical Procedures: Text and Methodology
Mathieu, D., Nony, J., Phan-Tan-Luu, R., NEMROD-W, LPRAI sarl, Marseille
MODDE v. 10, MKS Umetrics AB, Sweden
Orlandini, S., Giannini, I., Gotti, R., Pinzauti, S., La Porta, S., Furlanetto, S., (2007) Electrophoresis, 28, pp. 395-405
Ishikawa, K., (1985) What is Total Quality Control? The Japanese Way, , Prentice-Hall, Englewood Cliffs
Furlanetto, S., Pinzauti, S., La Porta, E., Chiarugi, A., Mura, P., Orlandini, S., (1998) J. Pharm. Biomed. Anal., 17, pp. 1015-1028
Pieraccini, G., Furlanetto, S., Orlandini, S., Bartolucci, G., Giannini, I., Pinzauti, S., Moneti, G., (2008) J. Chromatogr. A, 1180, pp. 138-150
Ermer, J., Miller, J.H., (2004) Method Validation in Pharmaceutical Analysis-A Guide to Best Practice, , McB. (Eds.), Wiley-VCH, Weinheim
Analytical quality by design in the development of a cyclodextrin-modified capillary electrophoresis method for the assay of metformin and its related substances
Quality by Design (QbD) is a new paradigm of quality to be applied to pharmaceutical products and processes, recently encouraged by International Conference on Harmonisation guidelines. In this paper QbD approach was applied to the development of a CE method for the simultaneous assay of metformin hydrochloride (MET) and its main impurities. QbD strategy was focused on electrophoretic process understanding, and the analytical method was thoroughly evaluated by applying risk assessment and chemometric tools. Method scouting allowed CD-CZE based on the addition of carboxymethyl-β-CD to Britton-Robinson acidic buffer to be chosen as operative mode. Seven critical process parameters (CPPs) were selected, related to capillary, injection, BGE and instrumental settings. The effect of the different levels of the CPPs on critical quality attributes (CQAs), e.g. critical resolution values and analysis time, was evaluated in a screening study. Response surface methodology led to draw contour plots and sweet spot plots. The definition of design space was accomplished by applying Monte-Carlo simulations, thus identifying by risk of failure maps a multivariate zone where the CQAs fulfilled the requirements with a selected probability. Finally, a control strategy was designed and the method was applied to a real sample of MET tablets. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.
Quality by Design (QbD) is a new paradigm of quality to be applied to pharmaceutical products and processes, recently encouraged by International Conference on Harmonisation guidelines. In this paper QbD approach was applied to the development of a CE method for the simultaneous assay of metformin hydrochloride (MET) and its main impurities. QbD strategy was focused on electrophoretic process understanding, and the analytical method was thoroughly evaluated by applying risk assessment and chemometric tools. Method scouting allowed CD-CZE based on the addition of carboxymethyl-β-CD to Britton-Robinson acidic buffer to be chosen as operative mode. Seven critical process parameters (CPPs) were selected, related to capillary, injection, BGE and instrumental settings. The effect of the different levels of the CPPs on critical quality attributes (CQAs), e.g. critical resolution values and analysis time, was evaluated in a screening study. Response surface methodology led to draw contour plots and sweet spot plots. The definition of design space was accomplished by applying Monte-Carlo simulations, thus identifying by risk of failure maps a multivariate zone where the CQAs fulfilled the requirements with a selected probability. Finally, a control strategy was designed and the method was applied to a real sample of MET tablets. © 2014 WILEY-VCH Verlag GmbH & Co. KGaA, Weinheim.
Analytical quality by design in the development of a cyclodextrin-modified capillary electrophoresis method for the assay of metformin and its related substances
No results. |
Analytical quality by design in the development of a cyclodextrin-modified capillary electrophoresis method for the assay of metformin and its related substances
Other filter: ([btitle,keywords] "Capillary Electropho ...
Cuocolo A, Pappata S, Zampella E, Assante R
* Advances in SPECT Methodology (306 views)
Int Rev Neurobiol (ISSN: 0074-77429780128154182, 2162-5514electronic), 2018 Sep; 141: 77-96.
Impact Factor: 3.36
View Export to BibTeX Export to EndNote
Giuffrida A, Maccarrone G, Cucinotta V, Orlandini S, Contino A
* Recent advances in chiral separation of amino acids using capillary electromigration techniques (178 views)
J Chromatogr A (ISSN: 0021-9673, 0021-9673linking), 2014 Oct 10; 1363: 41-50.
Impact Factor: 4.169
View Export to BibTeX Export to EndNote
Marasco D, Perretta G, Sabatella M, Ruvo M
* Past and Future Perspectives of Synthetic Peptide Libraries (550 views)
Curr Protein Pept Sci (ISSN: 1389-2037, 1389-2037linking), 2008 Oct; 9(5): 447-467.
Impact Factor: 3.011
View Export to BibTeX Export to EndNote
Lahr SJ, Engel DE, Stayrook SE, Maglio O, North B, Geremia S, Lombardi A, Degrado WF
* Analysis and design of turns in α-helical hairpins (471 views)
J Mol Biol (ISSN: 0022-2836, 1089-8638, 1089-8638electronic), 2005; 346(5): 1441-1454.
Impact Factor: 5.229
View Export to BibTeX Export to EndNote
Cucinotta V, Giuffrida A, La Mendola D, Maccarrone G, Puglisi A, Rizzarelli E, Vecchio G
* 3-Amino Derivative Of Beta-Cyclodextrin: Thermodynamics Of Copper (ii) Complexes And Exploitation Of Its Enantioselectivity In The Separation Of Amino Acid Racemates By Ligand Exchange Capillary Electrophoresis (350 views)
And Life Sciencesjournal Of Chromatography B Analytical Technologies In The Biomedical, 2004 Feb 5; 800(1-2): 127-133.
Impact Factor: 1.403
View Export to BibTeX Export to EndNote
Cucinotta V, Giuffrida A, Grasso G, Maccarrone G, Vecchio G
* Ligand exchange chiral separations by cyclodextrin derivatives in capillary electrophoresis (425 views)
Analyst (ISSN: 0003-2654), 2003; 128(2): 134-136.
Impact Factor: 2.251
View Export to BibTeX Export to EndNote
Cucinotta V, Giuffrida A, Grasso G, Maccarrone G, Messina M
* The Simultaneous Separation Of Different Enantiomeric Pairs In Capillary Electrophoresis By Mixing Different Hemispherodextrins, A Very Versatile Class Of Receptors (258 views)
J Chromatogr A (ISSN: 0021-9673, 0021-9673linking), 2002 Dec 6; 979(1-2): 137-145.
Impact Factor: 3.098
View Export to BibTeX Export to EndNote
* Advances in SPECT Methodology (306 views)
Int Rev Neurobiol (ISSN: 0074-77429780128154182, 2162-5514electronic), 2018 Sep; 141: 77-96.
Impact Factor: 3.36
View Export to BibTeX Export to EndNote
Giuffrida A, Maccarrone G, Cucinotta V, Orlandini S, Contino A
* Recent advances in chiral separation of amino acids using capillary electromigration techniques (178 views)
J Chromatogr A (ISSN: 0021-9673, 0021-9673linking), 2014 Oct 10; 1363: 41-50.
Impact Factor: 4.169
View Export to BibTeX Export to EndNote
Marasco D, Perretta G, Sabatella M, Ruvo M
* Past and Future Perspectives of Synthetic Peptide Libraries (550 views)
Curr Protein Pept Sci (ISSN: 1389-2037, 1389-2037linking), 2008 Oct; 9(5): 447-467.
Impact Factor: 3.011
View Export to BibTeX Export to EndNote
Lahr SJ, Engel DE, Stayrook SE, Maglio O, North B, Geremia S, Lombardi A, Degrado WF
* Analysis and design of turns in α-helical hairpins (471 views)
J Mol Biol (ISSN: 0022-2836, 1089-8638, 1089-8638electronic), 2005; 346(5): 1441-1454.
Impact Factor: 5.229
View Export to BibTeX Export to EndNote
Cucinotta V, Giuffrida A, La Mendola D, Maccarrone G, Puglisi A, Rizzarelli E, Vecchio G
* 3-Amino Derivative Of Beta-Cyclodextrin: Thermodynamics Of Copper (ii) Complexes And Exploitation Of Its Enantioselectivity In The Separation Of Amino Acid Racemates By Ligand Exchange Capillary Electrophoresis (350 views)
And Life Sciencesjournal Of Chromatography B Analytical Technologies In The Biomedical, 2004 Feb 5; 800(1-2): 127-133.
Impact Factor: 1.403
View Export to BibTeX Export to EndNote
Cucinotta V, Giuffrida A, Grasso G, Maccarrone G, Vecchio G
* Ligand exchange chiral separations by cyclodextrin derivatives in capillary electrophoresis (425 views)
Analyst (ISSN: 0003-2654), 2003; 128(2): 134-136.
Impact Factor: 2.251
View Export to BibTeX Export to EndNote
Cucinotta V, Giuffrida A, Grasso G, Maccarrone G, Messina M
* The Simultaneous Separation Of Different Enantiomeric Pairs In Capillary Electrophoresis By Mixing Different Hemispherodextrins, A Very Versatile Class Of Receptors (258 views)
J Chromatogr A (ISSN: 0021-9673, 0021-9673linking), 2002 Dec 6; 979(1-2): 137-145.
Impact Factor: 3.098
View Export to BibTeX Export to EndNote
7 Records (7 excluding Abstracts).
Total impact factor: 22.521 (22.521 excluding Abstracts).
Total 5 year impact factor: 21.417 (21.417 excluding Abstracts).
Total impact factor: 22.521 (22.521 excluding Abstracts).
Total 5 year impact factor: 21.417 (21.417 excluding Abstracts).
213 views. Last view on Tuesday 07 March 2023, 11:39:37
ibb.cnr.it
