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Factorial Design in Optimization of Chromatographic Separation of Ramipril and Its Impurities

Authorized Users Only
2010
Authors
Jančić-Stojanović, Biljana
Popović, Igor
Malenović, Anđelija
Ivanović, Darko
Medenica, Mirjana
Article (Published version)
Metadata
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Abstract
In this paper optimization of chromatographic retention of ramipril and its five impurities employing factorial design is presented. On the basis of preliminary experiments three factors were chosen as inputs (acetonitrile content, pH of the mobile phase and buffer concentration) and retention factor as output. As optimal full factorial design 2(3) was chosen, factors were examined at two different levels "low" and "high". Three replications at zero level were added in order to check linearity and complete statistical tests. Relationship between inputs and output is presented in form of second order interaction model. Adequacy of model was explained using analysis of variance. After analysis of results optimal chromatographic conditions were set. Separations were conducted on a C(18) column with a mixture of acetonitrile and water phase (TEA in potassium dihydrogen phosphate) in ratio 23:77 v/v. Finally, the LC method was validated and applied for quality control analysis of commercial...ly available tablets. The proposed method is simpler and faster as compared to existing official methods and therefore more adequate for routine control of ramipril during shelf life. Also a general approach which includes factorial design in method optimization offers a possibility for predicting and following the chromatographic behavior of such complex mixtures.

Keywords:
Column liquid chromatography / Factorial design / Ramipril
Source:
Chromatographia, 2010, 71, 9-10, 799-804
Publisher:
  • Springer Heidelberg, Heidelberg
Funding / projects:
  • Formulisanje i Karakterizacija separacionih sistema za modelovanje retencionog ponašanja lekovitih supstancija uz hemometrijsku evaluaciju (RS-142077)

DOI: 10.1365/s10337-010-1546-5

ISSN: 0009-5893

WoS: 000277595400009

Scopus: 2-s2.0-77953008811
[ Google Scholar ]
3
3
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/1416
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - JOUR
AU  - Jančić-Stojanović, Biljana
AU  - Popović, Igor
AU  - Malenović, Anđelija
AU  - Ivanović, Darko
AU  - Medenica, Mirjana
PY  - 2010
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1416
AB  - In this paper optimization of chromatographic retention of ramipril and its five impurities employing factorial design is presented. On the basis of preliminary experiments three factors were chosen as inputs (acetonitrile content, pH of the mobile phase and buffer concentration) and retention factor as output. As optimal full factorial design 2(3) was chosen, factors were examined at two different levels "low" and "high". Three replications at zero level were added in order to check linearity and complete statistical tests. Relationship between inputs and output is presented in form of second order interaction model. Adequacy of model was explained using analysis of variance. After analysis of results optimal chromatographic conditions were set. Separations were conducted on a C(18) column with a mixture of acetonitrile and water phase (TEA in potassium dihydrogen phosphate) in ratio 23:77 v/v. Finally, the LC method was validated and applied for quality control analysis of commercially available tablets. The proposed method is simpler and faster as compared to existing official methods and therefore more adequate for routine control of ramipril during shelf life. Also a general approach which includes factorial design in method optimization offers a possibility for predicting and following the chromatographic behavior of such complex mixtures.
PB  - Springer Heidelberg, Heidelberg
T2  - Chromatographia
T1  - Factorial Design in Optimization of Chromatographic Separation of Ramipril and Its Impurities
VL  - 71
IS  - 9-10
SP  - 799
EP  - 804
DO  - 10.1365/s10337-010-1546-5
ER  - 
@article{
author = "Jančić-Stojanović, Biljana and Popović, Igor and Malenović, Anđelija and Ivanović, Darko and Medenica, Mirjana",
year = "2010",
abstract = "In this paper optimization of chromatographic retention of ramipril and its five impurities employing factorial design is presented. On the basis of preliminary experiments three factors were chosen as inputs (acetonitrile content, pH of the mobile phase and buffer concentration) and retention factor as output. As optimal full factorial design 2(3) was chosen, factors were examined at two different levels "low" and "high". Three replications at zero level were added in order to check linearity and complete statistical tests. Relationship between inputs and output is presented in form of second order interaction model. Adequacy of model was explained using analysis of variance. After analysis of results optimal chromatographic conditions were set. Separations were conducted on a C(18) column with a mixture of acetonitrile and water phase (TEA in potassium dihydrogen phosphate) in ratio 23:77 v/v. Finally, the LC method was validated and applied for quality control analysis of commercially available tablets. The proposed method is simpler and faster as compared to existing official methods and therefore more adequate for routine control of ramipril during shelf life. Also a general approach which includes factorial design in method optimization offers a possibility for predicting and following the chromatographic behavior of such complex mixtures.",
publisher = "Springer Heidelberg, Heidelberg",
journal = "Chromatographia",
title = "Factorial Design in Optimization of Chromatographic Separation of Ramipril and Its Impurities",
volume = "71",
number = "9-10",
pages = "799-804",
doi = "10.1365/s10337-010-1546-5"
}
Jančić-Stojanović, B., Popović, I., Malenović, A., Ivanović, D.,& Medenica, M.. (2010). Factorial Design in Optimization of Chromatographic Separation of Ramipril and Its Impurities. in Chromatographia
Springer Heidelberg, Heidelberg., 71(9-10), 799-804.
https://doi.org/10.1365/s10337-010-1546-5
Jančić-Stojanović B, Popović I, Malenović A, Ivanović D, Medenica M. Factorial Design in Optimization of Chromatographic Separation of Ramipril and Its Impurities. in Chromatographia. 2010;71(9-10):799-804.
doi:10.1365/s10337-010-1546-5 .
Jančić-Stojanović, Biljana, Popović, Igor, Malenović, Anđelija, Ivanović, Darko, Medenica, Mirjana, "Factorial Design in Optimization of Chromatographic Separation of Ramipril and Its Impurities" in Chromatographia, 71, no. 9-10 (2010):799-804,
https://doi.org/10.1365/s10337-010-1546-5 . .

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