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Validation of an Oil-in-Water Microemulsion Liquid Chromatography Method for Analysis of Perindopril tert-Butylamine and Its Impurities

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Authors
Masković, Marija
Dotsikas, Yannis
Malenović, Anđelija
Jančić-Stojanović, Biljana
Ivanović, Darko
Medenica, Mirjana
Article (Published version)
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Abstract
This paper describes the development and validation of a microemulsion liquid chromatography (MELC) method for simultaneous determination of perindopril tert-butylamine and its impurities in bulk active substances and the pharmaceutical dosage form of tablets. An appropriate resolution with reasonable retention times was obtained for a microemulsion containing 0.24% (w/v) butyl acetate, 0.30% (w/v) ethyl acetate, 2% (w/v) sodium dodecyl sulfate, 7.75% (w/v) n-butanol, and 20.0 mM potassium dihydrogen phosphate, the pH of which was adjusted to 3.70 with 85% orthophosphoric acid. Separations were performed on a Nucleosil 120-5 butyl modified (C4), 250 x 4 mm, 5 pm particle size silica column at 40 degrees C, with a mobile phase flow rate of 1.25 mL/min. UV detection was performed at 254 nm. The established method was subjected to method validation, and required validation parameters were defined. Robustness testing, an important part of method validation, was performed as well. Since rob...ustness validation can be conducted using different experimental designs, the Plackett-Burman design was applied due to its possibility of testing many factors at the same time. The validated MELC method was found to be suitable for the simultaneous determination of perindopril tert-butylamine and its impurities in pharmaceuticals.

Source:
Journal of AOAC International, 2011, 94, 3, 723-734
Publisher:
  • AOAC Int, Gaithersburg
Funding / projects:
  • Formulisanje i Karakterizacija separacionih sistema za modelovanje retencionog ponašanja lekovitih supstancija uz hemometrijsku evaluaciju (RS-142077)

ISSN: 1060-3271

PubMed: 21796999

WoS: 000291775400005

Scopus: 2-s2.0-80051933606
[ Google Scholar ]
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8
Handle
https://hdl.handle.net/21.15107/rcub_farfar_1560
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/1560
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - JOUR
AU  - Masković, Marija
AU  - Dotsikas, Yannis
AU  - Malenović, Anđelija
AU  - Jančić-Stojanović, Biljana
AU  - Ivanović, Darko
AU  - Medenica, Mirjana
PY  - 2011
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1560
AB  - This paper describes the development and validation of a microemulsion liquid chromatography (MELC) method for simultaneous determination of perindopril tert-butylamine and its impurities in bulk active substances and the pharmaceutical dosage form of tablets. An appropriate resolution with reasonable retention times was obtained for a microemulsion containing 0.24% (w/v) butyl acetate, 0.30% (w/v) ethyl acetate, 2% (w/v) sodium dodecyl sulfate, 7.75% (w/v) n-butanol, and 20.0 mM potassium dihydrogen phosphate, the pH of which was adjusted to 3.70 with 85% orthophosphoric acid. Separations were performed on a Nucleosil 120-5 butyl modified (C4), 250 x 4 mm, 5 pm particle size silica column at 40 degrees C, with a mobile phase flow rate of 1.25 mL/min. UV detection was performed at 254 nm. The established method was subjected to method validation, and required validation parameters were defined. Robustness testing, an important part of method validation, was performed as well. Since robustness validation can be conducted using different experimental designs, the Plackett-Burman design was applied due to its possibility of testing many factors at the same time. The validated MELC method was found to be suitable for the simultaneous determination of perindopril tert-butylamine and its impurities in pharmaceuticals.
PB  - AOAC Int, Gaithersburg
T2  - Journal of AOAC International
T1  - Validation of an Oil-in-Water Microemulsion Liquid Chromatography Method for Analysis of Perindopril tert-Butylamine and Its Impurities
VL  - 94
IS  - 3
SP  - 723
EP  - 734
UR  - https://hdl.handle.net/21.15107/rcub_farfar_1560
ER  - 
@article{
author = "Masković, Marija and Dotsikas, Yannis and Malenović, Anđelija and Jančić-Stojanović, Biljana and Ivanović, Darko and Medenica, Mirjana",
year = "2011",
abstract = "This paper describes the development and validation of a microemulsion liquid chromatography (MELC) method for simultaneous determination of perindopril tert-butylamine and its impurities in bulk active substances and the pharmaceutical dosage form of tablets. An appropriate resolution with reasonable retention times was obtained for a microemulsion containing 0.24% (w/v) butyl acetate, 0.30% (w/v) ethyl acetate, 2% (w/v) sodium dodecyl sulfate, 7.75% (w/v) n-butanol, and 20.0 mM potassium dihydrogen phosphate, the pH of which was adjusted to 3.70 with 85% orthophosphoric acid. Separations were performed on a Nucleosil 120-5 butyl modified (C4), 250 x 4 mm, 5 pm particle size silica column at 40 degrees C, with a mobile phase flow rate of 1.25 mL/min. UV detection was performed at 254 nm. The established method was subjected to method validation, and required validation parameters were defined. Robustness testing, an important part of method validation, was performed as well. Since robustness validation can be conducted using different experimental designs, the Plackett-Burman design was applied due to its possibility of testing many factors at the same time. The validated MELC method was found to be suitable for the simultaneous determination of perindopril tert-butylamine and its impurities in pharmaceuticals.",
publisher = "AOAC Int, Gaithersburg",
journal = "Journal of AOAC International",
title = "Validation of an Oil-in-Water Microemulsion Liquid Chromatography Method for Analysis of Perindopril tert-Butylamine and Its Impurities",
volume = "94",
number = "3",
pages = "723-734",
url = "https://hdl.handle.net/21.15107/rcub_farfar_1560"
}
Masković, M., Dotsikas, Y., Malenović, A., Jančić-Stojanović, B., Ivanović, D.,& Medenica, M.. (2011). Validation of an Oil-in-Water Microemulsion Liquid Chromatography Method for Analysis of Perindopril tert-Butylamine and Its Impurities. in Journal of AOAC International
AOAC Int, Gaithersburg., 94(3), 723-734.
https://hdl.handle.net/21.15107/rcub_farfar_1560
Masković M, Dotsikas Y, Malenović A, Jančić-Stojanović B, Ivanović D, Medenica M. Validation of an Oil-in-Water Microemulsion Liquid Chromatography Method for Analysis of Perindopril tert-Butylamine and Its Impurities. in Journal of AOAC International. 2011;94(3):723-734.
https://hdl.handle.net/21.15107/rcub_farfar_1560 .
Masković, Marija, Dotsikas, Yannis, Malenović, Anđelija, Jančić-Stojanović, Biljana, Ivanović, Darko, Medenica, Mirjana, "Validation of an Oil-in-Water Microemulsion Liquid Chromatography Method for Analysis of Perindopril tert-Butylamine and Its Impurities" in Journal of AOAC International, 94, no. 3 (2011):723-734,
https://hdl.handle.net/21.15107/rcub_farfar_1560 .

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