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Validation of a Column Liquid Chromatographic Method for the Analysis of Pramipexole and Its Five Impurities

Authorized Users Only
2010
Authors
Malenović, Anđelija
Jančić-Stojanović, Biljana
Vemić, Ana
Ivanović, Darko
Medenica, Mirjana
Article (Published version)
Metadata
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Abstract
In this paper, a previously optimized method for HPLC analysis of pramipexole and its impurities was subjected to method validation in accordance with official regulations. The optimized chromatographic conditions were as follows: mobile phase acetonitrile water phase [15 + 85, v/v, water phase contained 1% triethylamine (TEA), pH adjusted to 7.0 with orthophosphoric acid]; detection at 262 nm for pramipexole, BI-II 751 xx, BI-II 786 BS, BI-II 820 BS, and 2-aminobenzothiazole and at 326 nm for BI-II 546 CL; column temperature, 25 degrees C; and flow rate, 1 mL/min. Acetonitrile and TEA content, pH of the water phase, flow rate, column temperature, and column type were factors studied in robustness testing. According to the experimental plan defined by a Plackett-Burman design, five dummy variables were added in order to have 12 factors. As output, resolution factor was chosen. Robustness was assessed by graphical (half-normal probability plots and Pareto charts) and statistical (t-test...) methods. Also, nonsignificance intervals for significant factors were estimated, and limits for the system suitability test were determined. Finally, linearity, accuracy, and precision of the proposed HPLC method were defined. LOD and LOQ values for analyzed impurities were determined. The method was completely defined by these experiments.

Source:
Journal of AOAC International, 2010, 93, 4, 1102-1112
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: 20922940

WoS: 000281492100007

Scopus: 2-s2.0-77956141233
[ Google Scholar ]
20
16
Handle
https://hdl.handle.net/21.15107/rcub_farfar_1346
URI
https://farfar.pharmacy.bg.ac.rs/handle/123456789/1346
Collections
  • Radovi istraživača / Researchers’ publications
Institution/Community
Pharmacy
TY  - JOUR
AU  - Malenović, Anđelija
AU  - Jančić-Stojanović, Biljana
AU  - Vemić, Ana
AU  - Ivanović, Darko
AU  - Medenica, Mirjana
PY  - 2010
UR  - https://farfar.pharmacy.bg.ac.rs/handle/123456789/1346
AB  - In this paper, a previously optimized method for HPLC analysis of pramipexole and its impurities was subjected to method validation in accordance with official regulations. The optimized chromatographic conditions were as follows: mobile phase acetonitrile water phase [15 + 85, v/v, water phase contained 1% triethylamine (TEA), pH adjusted to 7.0 with orthophosphoric acid]; detection at 262 nm for pramipexole, BI-II 751 xx, BI-II 786 BS, BI-II 820 BS, and 2-aminobenzothiazole and at 326 nm for BI-II 546 CL; column temperature, 25 degrees C; and flow rate, 1 mL/min. Acetonitrile and TEA content, pH of the water phase, flow rate, column temperature, and column type were factors studied in robustness testing. According to the experimental plan defined by a Plackett-Burman design, five dummy variables were added in order to have 12 factors. As output, resolution factor was chosen. Robustness was assessed by graphical (half-normal probability plots and Pareto charts) and statistical (t-test) methods. Also, nonsignificance intervals for significant factors were estimated, and limits for the system suitability test were determined. Finally, linearity, accuracy, and precision of the proposed HPLC method were defined. LOD and LOQ values for analyzed impurities were determined. The method was completely defined by these experiments.
PB  - AOAC Int, Gaithersburg
T2  - Journal of AOAC International
T1  - Validation of a Column Liquid Chromatographic Method for the Analysis of Pramipexole and Its Five Impurities
VL  - 93
IS  - 4
SP  - 1102
EP  - 1112
UR  - https://hdl.handle.net/21.15107/rcub_farfar_1346
ER  - 
@article{
author = "Malenović, Anđelija and Jančić-Stojanović, Biljana and Vemić, Ana and Ivanović, Darko and Medenica, Mirjana",
year = "2010",
abstract = "In this paper, a previously optimized method for HPLC analysis of pramipexole and its impurities was subjected to method validation in accordance with official regulations. The optimized chromatographic conditions were as follows: mobile phase acetonitrile water phase [15 + 85, v/v, water phase contained 1% triethylamine (TEA), pH adjusted to 7.0 with orthophosphoric acid]; detection at 262 nm for pramipexole, BI-II 751 xx, BI-II 786 BS, BI-II 820 BS, and 2-aminobenzothiazole and at 326 nm for BI-II 546 CL; column temperature, 25 degrees C; and flow rate, 1 mL/min. Acetonitrile and TEA content, pH of the water phase, flow rate, column temperature, and column type were factors studied in robustness testing. According to the experimental plan defined by a Plackett-Burman design, five dummy variables were added in order to have 12 factors. As output, resolution factor was chosen. Robustness was assessed by graphical (half-normal probability plots and Pareto charts) and statistical (t-test) methods. Also, nonsignificance intervals for significant factors were estimated, and limits for the system suitability test were determined. Finally, linearity, accuracy, and precision of the proposed HPLC method were defined. LOD and LOQ values for analyzed impurities were determined. The method was completely defined by these experiments.",
publisher = "AOAC Int, Gaithersburg",
journal = "Journal of AOAC International",
title = "Validation of a Column Liquid Chromatographic Method for the Analysis of Pramipexole and Its Five Impurities",
volume = "93",
number = "4",
pages = "1102-1112",
url = "https://hdl.handle.net/21.15107/rcub_farfar_1346"
}
Malenović, A., Jančić-Stojanović, B., Vemić, A., Ivanović, D.,& Medenica, M.. (2010). Validation of a Column Liquid Chromatographic Method for the Analysis of Pramipexole and Its Five Impurities. in Journal of AOAC International
AOAC Int, Gaithersburg., 93(4), 1102-1112.
https://hdl.handle.net/21.15107/rcub_farfar_1346
Malenović A, Jančić-Stojanović B, Vemić A, Ivanović D, Medenica M. Validation of a Column Liquid Chromatographic Method for the Analysis of Pramipexole and Its Five Impurities. in Journal of AOAC International. 2010;93(4):1102-1112.
https://hdl.handle.net/21.15107/rcub_farfar_1346 .
Malenović, Anđelija, Jančić-Stojanović, Biljana, Vemić, Ana, Ivanović, Darko, Medenica, Mirjana, "Validation of a Column Liquid Chromatographic Method for the Analysis of Pramipexole and Its Five Impurities" in Journal of AOAC International, 93, no. 4 (2010):1102-1112,
https://hdl.handle.net/21.15107/rcub_farfar_1346 .

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