Capillary electrophoretic methods for quality control analyses of pharmaceuticals: A review.


Journal

Electrophoresis
ISSN: 1522-2683
Titre abrégé: Electrophoresis
Pays: Germany
ID NLM: 8204476

Informations de publication

Date de publication:
01 2021
Historique:
received: 29 06 2020
revised: 08 08 2020
accepted: 14 08 2020
pubmed: 10 9 2020
medline: 31 8 2021
entrez: 9 9 2020
Statut: ppublish

Résumé

Capillary electrophoresis represents a promising technique in the field of pharmaceutical analysis. The presented review provides a summary of capillary electrophoretic methods suitable for routine quality control analyses of small molecule drugs published since 2015. In total, more than 80 discussed methods are sorted into three main sections according to the applied electroseparation modes (capillary zone electrophoresis, electrokinetic chromatography, and micellar, microemulsion, and liposome-electrokinetic chromatography) and further subsections according to the applied detection techniques (UV, capacitively coupled contactless conductivity detection, and mass spectrometry). Key parameters of the procedures are summarized in four concise tables. The presented applications cover analyses of active pharmaceutical ingredients and their related substances such as degradation products or enantiomeric impurities. The contribution of reported results to the current knowledge of separation science and general aspects of the practical applications of capillary electrophoretic methods are also discussed.

Identifiants

pubmed: 32901975
doi: 10.1002/elps.202000185
doi:

Substances chimiques

Pharmaceutical Preparations 0

Types de publication

Journal Article Research Support, Non-U.S. Gov't Review

Langues

eng

Sous-ensembles de citation

IM

Pagination

19-37

Informations de copyright

© 2020 Wiley-VCH GmbH.

Références

Alsante, K. M., Huynh-Ba, K. C., Baertschi, S. W., Reed, R. A., Landis, M. S., Furness, S., Olsen, B., Mowery, M., Russo, K., Iser, R., Stephenson, G. A., Jansen, P., AAPS Pharm Sci Tech 2014, 15, 237-251.
International Council on Harmonization Guideline Q3A(R2), Impur. N. Drug Subst. 2006, 1-15.
Görög, S., Trends Anal. Chem. 2018, 101, 2-16.
Voeten R. L. C., Ventouri I. K., Haselberg R., Somsen G. W., Anal. Chem. 2018, 90, 1464-1481.
Singh, S., Handa, T., Narayanam, M., Sahu, A., Junwal, M., Shah, R. P., J. Pharm. Biomed. Anal. 2012, 69, 148-173.
Jain, D., Basniwal, P. K., J. Pharm. Biomed. Anal. 2013, 86, 11-35.
Liu, D. Q., Kord, A. S., Trends Anal. Chem. 2013, 108-117.
Maggio, R. M., Vignaduzzo, S. E., Kaufman, T. S., Trends Anal. Chem. 2013, 49, 57-70.
El Deeb, S., Wätzig, H., Abd El-Hady, D., Albishri, H. M., Sänger-van de Griend, C., Scriba, G. K. E., Electrophoresis 2014, 35, 170-189.
El Deeb, S., Wätzig, H., Abd El-Hady, D., Sänger-van de Griend, C., Scriba, G. K. E., Electrophoresis 2016, 37, 1591-1608.
Holm, R., Elder, D. P., Eur. J. Pharm. Sci. 2016, 87, 118-135.
Ramachandra, B., Crit. Rev. Anal. Chem. 2017, 47, 24-36.
Gumustas, M., Ozkan, S. A., Chankvetadze, B., Cur. Med. Chem. 2018, 25, 4152-4188.
Štěpánová, S., Kašička, V., J. Sep. Sci. 2014, 37, 2039-2055.
Zhu, Q., Scriba, G. K. E., J. Pharm. Biomed. Anal. 2018, 147, 425-438.
Kumar, M., Bhatia, R., Rawal, R. K., J. Pharm. Biomed. Anal. 2018, 157, 122-136.
Scriba, G. K. E., J. Pharm. Biomed. Anal. 2011, 55, 688-701.
Jáč, P., Scriba, G. K. E., J. Sep. Sci. 2013, 36, 52-74.
Hancu, G., Budău, M., Muntean, D. L., Gagyi, L., Rusu, A., Biomed. Chromatogr. 2018, 32, e4335.
Casado, N., Valimaña-Traverso, J., García, M. Á., Marina, M. L., Crit. Rev. Anal. Chem. 2019, 1, 1-31.
Zalewska, M., Wilk, K., Milnerowicz, H., Acta Pol. Pharm. Drug Res. 2013, 70, 171-180.
Ha, N. S., Sadeghi, S., van Dam, R. M., Micromachines 2017, 8, 337.
Paul, P., Sänger-van de Griend, C., Adams, E., Van Schepdael, A., J. Pharm. Biomed. Anal. 2018, 158, 405-415.
Pioch, M., Bunz, S.-C., Neusüß, C., Electrophoresis 2012, 33, 1517-1530.
Guttman, A., Trends Anal. Chem. 2013, 48, 132-143.
Tamizi, E., Jouyban, A., Electrophoresis 2015, 36, 831-858.
Gahoual, R., Beck, A., Leize-Wagner, E., François, Y. N., J. Chromatogr. B: Anal. Technol. Biomed. Life Sci. 2016, 1032, 61-78.
Lechner, A., Giorgetti, J., Gahoual, R., Beck, A., Leize-Wagner, E., François, Y. N., J. Chromatogr. B: Anal. Technol. Biomed. Life Sci. 2019, 1122-1123, 1-17.
Toraño, J. S., Ramautar, R., de Jong, G., J. Chromatogr. B: Anal. Technol. Biomed. Life Sci. 2019, 1118-1119, 116-136.
Neuberger, S., Jooß, K., Ressel, C., Neusüß, C., Anal. Bioanal. Chem. 2016, 408, 8701-8712.
Neuberger, S., Jooß, K., Flottmann, D., Scriba, G. K. E., Neusüß, C., J. Pharm. Biomed. Anal. 2017, 134, 122-129.
Ahmed, H. M., Belal, T. S., Shaalan, R. A., El Yazbi, F. A., Elonsy, S. M., Acta Chromatogr. 2020, 32, 219-227.
Mufusama, J.-P., Hoellein, L., Feineis, D., Holzgrabe, U., Bringmann, G., Electrophoresis 2018, 39, 2530-2539.
Abdelwahab, N. S., Farid, N. F., Elagawany, M., Abdelmomen, E. H., Biomed. Chromatogr. 2018, 32, e4346.
Pallotta, A., Boudier, A., Leroy, P., Clarot, I., J. Chromatogr. A 2016, 1461, 179-184.
Pallotta, A., Boudier, A., Creusot, B., Brun, E., Sicard-Roselli, C., Bazzi, R., Roux, S., Clarot, I., Int. J. Pharm. 2019, 569, 118583.
Antuganov, D., Antuganova, Y., Zykova, T., Krasikova, R., J. Pharm. Biomed. Anal. 2019, 173, 68-74.
Maher, H. M., Abdelrahman, A. E., Alzoman, N. Z., Aljohar, H. I., J. Liq. Chromatogr. R. T. 2019, 42, 161-171.
Guichard, N., Ogereau, M., Falaschi, L., Rudaz, S., Schappler, J., Bonnabry, P., Fleury-Souverain, S., Electrophoresis 2018, 39, 2512-2520.
de Souza, A., Kedor-Hackmann, E. R. M., Santoro, M. I. R. M., Aurora-Prado, M. S., Sep. Sci. Plus 2019, 2, 253-261.
Furlanetto, S., Orlandini, S., Pasquini, B., Caprini, C., Mura, P., Pinzauti, S., Anal. Bioanal. Chem. 2015, 407, 7637-7646.
Ragab, M. A. A., Abdel-Hay, M. H., J. AOAC Int. 2019, 102, 473-479.
Gotti, R., Fiori, J., Liverani, L., Spelta, F., Electrophoresis 2015, 36, 2820-2827.
Duarte, L. M., Amorim, T. L., Chellini, P. R., Adriano, L. H. C., de Oliveira M. A. L., J. Sep. Sci. 2018, 41, 4533-4543.
Al Alamein, A. M. A., Saad, A. S., Galal, M. M., Zaazaa, H. E., JPC: J. Planar Chromat. 2018, 31, 280-289.
de Oliveira, C. L. C. G., Salgado, H. R. N., de Lourdes Leite Moraes, M., Braz. J. Pharm. Sci. 2018, 54, e17585.
Ansar, S. M., Jiang, W., Mudalige, T., Int. J. Pharm. 2018, 549, 109-114.
Maruszak, W., Cybulski, M., J. Pharm. Biomed. Anal. 2015, 105, 32-38.
Kogawa, A. C., Van Schepdael, A., Salgado, H. R. N., J. Chromatogr. Sci. 2019, 57, 476-483.
Lago, M. W., Friedrich, M. L., Iop, G. D., de Souza, T. B., de Azevedo Mello, P., Adams, A. I. H., Talanta 2018, 181, 182-189.
Fayed, A. S., Rezk, M. R., Marzouk, H. M., Abbas, S. S., J. Chromatogr. Sci. 2018, 56, 461-471.
Orlandini, S., Pasquini, B., Caprini, C., Del Bubba, M., Pinzauti, S., Furlanetto, S., Electrophoresis 2015, 36, 2642-2649.
Merli, D., Profumo, A., Dossi, C., J. Pharm. Anal. 2012, 2, 450-453.
Nguyen, T. A. H., Pham, T. N. M., Le, T. B., Le, D. C., Tran, T. T. P., Nguyen, T. Q. H., Nguyen, T. K. T., Hauser, P. C., Mai, T. D., J. Chromatogr. A 2019, 1605, 360356.
Marra, M. C., Cunha, R. R., Muñoz, R. A. A., Batista, A. D., Richter, E.M., J. Sep. Sci. 2017, 40, 3557-3562.
Paul, P., Duchateau, T., Sänger-van de Griend, C., Adams, E., Van Schepdael, A., J. Sep. Sci. 2017, 40, 3535-3544.
Cunha, R. R., Chaves, S. C., Ribeiro, M. M., Torres, L. M., Muñoz, R. A., Dos Santos, W. T., Richter, E. M., J. Sep. Sci. 2015, 38, 1657-1662.
Paul, P., Van Laeken, C., Sänger-van de Griend, C., Adams, E., Van Schepdael, A., J. Pharm. Biomed. Anal. 2016, 129, 1-8.
Xia, J. Q., Zhang, L., Capillary Electrophoresis-Mass Spectrometry: Therapeutic Protein Characterization, Springer International Publishing, Cham 2016.
van Wijk, A. M., Niederländer, H. A., van Ogten, M. D., de Jong, G. J., Anal. Chim. Acta 2015, 874, 75-83.
van Wijk, A. M., Niederländer, H. A. G., Vervaart, M. A. T., Siebum, A. H. G., de Jong, G. J., J. Pharm. Biomed. Anal. 2013, 74, 133-140.
Sánchez-Hernández, L., Guijarro-Diez, M., Marina, M. L., Crego, A. L., Electrophoresis 2014, 35, 12-27.
Tsioupi, D. A., Stefan-van Staden, R. I., Kapnissi-Christodoulou, C. P., Electrophoresis 2013, 34, 178-204.
Dixit, S., Park, J. H., Biomed. Chromatogr. 2014, 28, 10-26.
Sánchez-López, E., Castro-Puyana, M., Marina, M. L., Crego, A. L., in: Anderson, J. L., Berthod, A., Pino, V., Stalcup, A. M. (Eds.), Analytical Separation Science, Wiley-VCH-Books, Weinheim 2015, pp. 731-744.
Stavrou, I. J., Mavroudi, M. C., Kapnissi-Christodoulou, C. P., Electrophoresis 2015, 36, 101-123.
Saz, J. M., Marina, M. L., J. Chromatogr. A 2016, 1467, 79-94.
Stavrou, I. J., Agathokleous, E. A., Kapnissi-Christodoulou, C. P., Electrophoresis 2017, 38, 786-819.
Ribeiro, A. R., Maia, A. S., Cass, Q. B., Tiritan, M. E., J. Chromatogr. B: Anal. Technol. Biomed. Life Sci. 2014, 968, 8-21.
International Council on Harmonization Guideline Q3B(R2), Impur. N. Drug Subst. 2006, 1-14.
Adamusová, H., Novotná, N., Bosáková, Z., Douša, M., Chromatographia 2017, 80, 559-563.
Krait, S., Douša, M., Scriba, G. K. E., Chromatographia 2016, 79, 1343-1350.
Hancu, G., Budău, M., Kántor, L. K., Cârje, A., Adv. Pharm. Bull. 2015, 5, 35-40.
Xiao, H., Fu, X., Liang, S., Li, Y., Bao, J. J., Zhang, Y., J. Chromatogr. A 2015, 1408, 250-254.
Shafaati, A., Zarghi, A., Sattary Javid, F., Iran. J. Pharm. Res. 2018, 17, 505-512.
Ginterová, P., Znaleziona, J., Knob, R., Douša, M., Petr, J., Ševčík, J., Chem. Pap. 2016, 70, 1024-1030.
Pasquini, B., Orlandini, S., Villar-Navarro, M., Caprini, C., Del Bubba, M., Douša, M., Giuffrida, A., Gotti, R., Furlanetto, S., J. Chromatogr. A 2018, 1568, 205-213.
Menéndez-López, N., Valimaña-Traverso, J., Castro-Puyana, M., Salgado, A., García, M. Á., Marina, M. L., J. Pharm. Biomed. Anal. 2017, 138, 189-196.
Harnisch, H., Scriba, G. K. E., J. Pharm. Biomed. Anal. 2019, 162, 257-263.
Bawazeer, S. S., Abdel-Megied, A. M., Bebawy, L. I., Chromatographia 2016, 79, 1533-1542.
Krait, S., Scriba, G. K. E., Electrophoresis 2018, 39, 2575-2580.
Krait, S., Heuermann, M., Scriba, G. K. E., J. Sep. Sci. 2018, 41, 1405-1413.
Cârcu-Dobrin, M., Budău, M., Hancu, G., Gagyi, L., Rusu, A., Kelemen, H., Saudi Pharm. J. 2017, 25, 397-403.
Varga, E., Sohajda, T., Juvancz, Z., Bodane Kendrovics, R., Szekely, E., Bansaghi, G., Chromatographia 2015, 78, 881-888.
Papp, L. A., Hancu, G., Gyéresi, Á., Kelemen, H., Szabó, Z.-I., Noszál, B., Dubský, P., Tóth, G., Electrophoresis 2019, 40, 2799-2805.
Chung, H. K., Truong, Q.-K., Mai, X.-L., Choi, Y., Kang, J.-S., Mar, W., Kim, K. H., Arch. Pharm. Res. 2017, 40, 962-971.
Szabó, Z.-I., Foroughbakhshfasaei, M., Gál, R., Horváth, P., Komjáti, B., Noszál, B., Tóth, G., J. Sep. Sci. 2018, 41, 1414-1423.
Lourenço, L. P., Aguiar, F. A., de Oliveira, A. R., de Gaitani, C. M., J. Anal. Methods Chem. 2015, 2015, 294270.
Niedermeier, S., Scriba, G.K.E., Chromatographia 2020, 83, 123-129.
Niedermeier, S., Scriba, G. K. E., J. Pharm. Biomed. Anal. 2017, 146, 402-409.
Michalska, K., Gruba, E., Cielecka-Piontek, J., Bednarek, E., J. Pharm. Biomed. Anal. 2016, 120, 402-412.
Zhu, B., Xu, S., Guo, X., Wie, L., Yu, J., Wang, T., J. Sep. Sci. 2017, 40, 1784-1795.
Hancu, G., Papp, L. A., Rusu, A., Chromatographia 2015, 78, 279-284.
Kanizsová, L., Ansorge, M., Zusková, I., Dubský, P., J. Chromatogr. A 2018, 1568, 214-221.
Szabó, Z.-I., Gál, R., Szőcs, L., Ludmerczki, R., Muntean, D.-L., Noszál, B., Tóth, G., Electrophoresis 2017, 38, 1886-1894.
Harnisch, H., Chien, Y., Scriba, G. K. E., Chromatographia 2018, 81, 719-725.
Fang, L., Du, Y., Hu, X., Luo, L., Guo, X., Guo, X., Yu, J., Biomed. Chromatogr. 2017, 31, e3991.
Martínez-Girón, A. B., Marina, M. L., Crego, A. L., J. Chromatogr. A 2016, 1467, 427-435.
Szabó, Z.-I., Ludmerczki, R., Fiser, B., Noszál, B., Tóth, G., Electrophoresis 2019, 40, 1897-1903.
Meng, R., Kang, J., J. Chromatogr. A 2017, 1506, 120-127.
Orlandini, S., Pasquini, B., Del Bubba, M., Pinzauti, S., Furlanetto, S., J. Chromatogr. A 2015, 1380, 177-185.
Znaleziona, J., Fejős, I., Ševčík, J., Douša, M., Béni, S., Maier, V., J. Pharm. Biomed. Anal. 2015, 105, 10-16.
Naghdi, E., Fakhari, A. R., Chirality 2018, 30, 1161-1168.
Lee, K. R., Nguyen, N. T., Lee, Y. J., Choi, S., Kang, J. S., Mar, W., Kim, K. H., Arch. Pharm. Res. 2015, 38, 826-833.
Li, Z., Xue, J., Guo, X., He, Q., J. Chem. Pharm. Res. 2015, 7, 118-121.
Kazsoki, A., Fejős, I., Sohajda, T., Zhou, W., Hu, W., Szente, L., Béni, S., Electrophoresis 2016, 37, 1318-1325.
Li, X., Li, Y., Zhao, L., Shen, J., Zhang, Y., Bao, J.J., Electrophoresis 2014, 35, 2788-2784.
Wang, Y., Zhang, S., Breitbach, Z. S., Petersen, H., Ellegaard, P., Armstrong, D. W., Electrophoresis 2016, 37, 841-848.
Sonnendecker, C., Thürmann, S., Przybylski, C., Zitzmann, F. D., Heinke, N., Krauke, Y., Monks, K., Robitzki, A. A., Belder, D., Zimmermann, W., Angew. Chem., Int. Ed. 2019, 58, 6411-6414.
Wahl, J., Holzgrabe, U., J. Res. Anal. 2017, 3, 73-80.
Wahl, J., Holzgrabe, U., J. Pharm. Biomed. Anal. 2018, 148, 245-250.
Orlandini, S., Pasquini, B., Caprini, C., Del Bubba, M., Douša, M., Pinzauti, S., Furlanetto, S., J. Chromatogr. A 2016, 1467, 363-371.
Pasquini, B., Orlandini, S., Caprini, C., Del Bubba, M., Innocenti, M., Brusotti, G., Furlanetto, S., Talanta 2016, 160, 332-339.
Doomkaew, A., Prutthiwanasan, B., Suntornsuk, L., J. Pharm. Biomed. Anal. 2015, 102, 119-128.
Riasová, P., Doubková, D., Pincová, L., Jung, O., Polášek, M., Jáč, P., Electrophoresis 2018, 39, 2550-2557.
W Ibrahim, W. A., Arsad, S. R., Maarof, H., Sanagi, M. M., Aboul-Enein, H. Y., Chirality 2015, 27, 223-227.
Flor, S., Huala Juan, M., Tripodi, V., Lucangioli, S., Electrophoresis 2016, 37, 2420-2428.
Bastos, C. A., Gomes, C. R. B., de Souzab, M. V. N., de Oliveira, M. A. L., J. Braz. Chem. Soc. 2015, 26, 887-898.
Liu, Y., Wang, X., Chirality 2017, 29, 422-429.
Hu, S.-Q., Shi, H.-J., Yu, H., Dong, J., Guo, X.-M., Electrophoresis 2015, 36, 2762-2767.
Kaale, E., Höllein, L., Holzgrabe, U., Electrophoresis 2015, 36, 2736-2744.
Orlandini, S., Pasquini, B., Caprini, C., Del Bubba, M., Squarcialupi, L., Colotta, V., Furlanetto, S., J. Chromatogr. A 2016, 1466, 189-198.
Li, X., Du, Y., Feng, Z., Sun, X., Huang, Z., J. Pharm. Biomed. Anal. 2017, 145, 186-194.
Pasquini, B., Melani, F., Caprini, C., Del Bubba, M., Pinzauti, S., Orlandini, S., Furlanetto, S., J. Pharm. Biomed. Anal. 2017, 144, 220-229.
Caprini, C., Pasquini, B., Melani, F., Del Bubba, M., Giuffrida, A., Calleri, E., Orlandini, S., Furlanetto, S., J. Pharm. Biomed. Anal. 2018, 149, 249-257.
Jarvas, G., Guttman, A., Miekus, N., Baczek, T., Jeong, S., Chung, D.S., Patoprstý, V., Masar, M., Hutta, M., Datinska, V., Foret, F., TrAC Trends Anal. Chem. 2020, 122, 115702.

Auteurs

Roman Řemínek (R)

Institute of Analytical Chemistry, Czech Academy of Sciences, Brno, Czech Republic.

František Foret (F)

Institute of Analytical Chemistry, Czech Academy of Sciences, Brno, Czech Republic.

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