Factorial Design in Optimization of Chromatographic Separation of Ramipril and Its Impurities
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2010
Authors
Jančić-Stojanović, Biljana
Popović, Igor
Malenović, Anđelija

Ivanović, Darko
Medenica, Mirjana
Article (Published version)

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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 / RamiprilSource:
Chromatographia, 2010, 71, 9-10, 799-804Publisher:
- Springer Heidelberg, Heidelberg
Funding / projects:
DOI: 10.1365/s10337-010-1546-5
ISSN: 0009-5893
WoS: 000277595400009
Scopus: 2-s2.0-77953008811
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PharmacyTY - 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 . .