Leyla KARADURMUŞ, Mehmet GÜMÜŞTAŞ, Sevinç KURBANOĞLU, Bengi USLU, Sibel A. ÖZKAN

A novel core-shell-based chromatographic method supported by ratio derivative spectrophotometry for the simultaneous determination of perindopril, indapamide, and amlodipine ternary mixtures

In this work, ratio spectra of the first derivative spectrophotometric and liquid chromatographic methods have been described for the first time for the simultaneous determination of perindopril (PER), indapamide (IND), and amlodipine (AML) in dosage forms. For chromatographic separations several mobile phase compositions were tested for efficient separation with the use of a new column technology related to superficially porous particles. Optimum chromatographic separation was achieved using a Kinetex C18 column (150 ×× 4.6 mm I.D. 5 μμm) at a flow rate of 1.5 mL min−1−1. The separation was carried out at 30 ∘∘C and the diode array detector was adjusted to 215 nm. As a comparison, a spectrophotometric method depending on the first derivative of the ratio spectra was developed. The first derivative of the ratio amplitudes at 227.2 nm for PER, 269.4 nm for AML, 292.0 nm for IND were selected. The proposed methods were successfully applied for the simultaneous assay of the drug combination in pharmaceutical dosage forms and the methods were compared to each other in terms of Student t and F tests for the comparison of their accuracy and precision parameters.

Keywords:

Amlodipine, indapamide, perindopril, ratio derivative spectrophotometry, high performance liquid chro- matography,

PDF

___

Todd, P.A.; Fitton, A. Drugs 1991 , 42 , 90-114.
Morgan, T.; Anderson, A. Clin. Exp. Pharmacol. Physiol. 1992 , 19 , 61-65.
Silvestre, J. E.; Kamsu-Kom, N.; Clergue, M.; Duriez, M.; Evy, B. I. J. Pharmacol. Exp. Ther. 2002 , 303 , 1038- 1043.
Louis, W. J.; Conway, E. L.; Krum, H.; Workman, B.; Drummer, O. H.; Lam, W.; Phillips, P.; Howes, L. G.; Jackson, B. Clin. Exp. Pharmacol. Physiol. 1992 , 19 , 55-60.
Elliott, H. L. Clin. Pharmacokinet . 1992 , 22 , 22-31.
Murdoch, D.; Heel, R. C.; Abernethy, D. R.; Frishman, W. H.; Johns, E. J.; Mroczek, W. J. Drugs 1991 , 41 , 478-505.
Scholz, H. Cardiovasc. Drugs Ther. 1997 , 10 , 869-872.
Quartermain, D.; Hawxhurst, A.; Ermita, B.; Puente, J. Q. Behav. Neural Biol. 1993 , 60 , 211-219.
Campbell, D. B.; Moore, R. A. Postgrad. Med. J. 1981 , 57 (Suppl. 2) , 7-17.
Bataillard, A.; Schiavi, P.; Sassard, J. J. Clin Pharmacokinet . 1999 , 37 , 7-12.
Chaffman, M.; Heel, R. C.; Brogden, R. N.; Speight, T. M.; Avery, G. S. Drugs 1984 , 28 , 189-235.
Moore, R. A.; Seki, T.; Ohsumi, S.; Oheim, K.; Kyncl, J.; Desnoyers, P. Curr. Med. Res. Opin. 1977 , 5 , 25-32.
Möttönen, T.; Hannonen, P.; Leirisalo-Repo, M.; Nissilä, M.; Kautiainen, H.; Korpela, M.; Laasonen, L.; Julkunen, H.; Luukkainen, R.; Vuori, K. et al., Lancet 1999 , 353 , 1568-1573.
Chou, T. C. Pharmacol. Rev. 2006 , 58 , 621-81.
Anushka, P. Lancet 2007 , 370 , 829-840.
Antonaccio, M. J. Annu. Rev. Pharmacol. Toxicol. 1982 , 22 , 57-87.
Messerli, F. H.; Oparil, S.; Feng, Z. Am. J. Cardiol. 2000 , 86 , 1182-1187.
Menard, J.; Patchett, A. A. Adv. Protein Chem. 2001 , 56 , 13-75.
Gumustas, M.; Kurbanoglu, S.; Uslu, B.; Ozkan, S. A. Chromatographia 2013 , 76 , 1365-1427.
Fekete, S.; Fekete, J.; Ganzler, K. J. Pharm. Biomed. Anal. 2009 , 49 , 64-71.
Gumustas, M.; Alshana, U.; Ertas, N.; Goger, N. G.; Ozkan, S. A.; Uslu, B. J. Pharm. Biomed. Anal. 2016 , 124 , 390-398.
Gritti, F.; Guiochon, G. J. Chromatogr. A 2014 , 1333 , 60-69.
Fekete, S.; Oláh, E.; Fekete, J. J. Chromatogr. A 2012 , 1228 , 57-71.
Gritti, F.; Guiochon, G. Chem. Eng. Sci. 2010 , 65 , 6310-6319.
Fekete, S.; Ganzler, K.; Fekete, J. J. Pharm. Biomed. Anal. 2011 , 54 , 482-490.
Patel, D. B.; Mehta, F. A.; Bhatt, K. K. Sci. Pharm. 2012 , 80 , 581-590.
Zaazaa, H. E.; Abbas, S. S.; Essam, H. A. M.; El-Bardicy, M. G. J. Chromatogr. Sci. 2013 , 51 , 533-543.
Riyaz, S.; Vasanth, P.; Ramesh, M.; Ramesh, M.; Ramesh, T. Int. J. Chem. Life Sci. 2012 , 1 , 1033-1038.
Rashmita, G.; Vasanth, P. M.; Ramesh, T.; Ramesh, M. Der Pharma Chem. 2013 , 5 , 347-352.
Gizawy, S. M.; Bebawy, L. I.; Abdelmageed, O. H.; Omar, M. A.; Deryea, S. M.; Abdel-Megied, A. M. J. Liq. Chromatogr. Relat. Technol. 2013 , 36 , 1323-1339.
United States Pharmacopeial Convention. United States Pharmacopeia (The USP 40), The Official Compendia of Standards ; United States Pharmacopeial Convention: Rockville, MD, USA, 2017.
Swartz ME, Analytical Method Development and Validation ; Marcel Dekker: New York, NY, USA, 1997.
Ermer, J.; Miller, J. Method Validation in Pharmaceutical Analysis ; Wiley-VCH: Weinheim, Germany 2005.
Riley, CM.; Rosanske, T. Development and Validation of Analytical Methods ; Elsevier: Amsterdam, the Netherlands, 1996.
International Conference on Harmonization. ICH Guidelines - Topic Validation of Analytical Procedures: Method- ology ; International Conference on Harmonization: Brussels, Belgium, 1995.