Optimization of a forced degradation study of atorvastatin employing an experimental design approach
| Autor: | Maja Hadzieva Gigovska, Ana Petkovska, Jelena Acevska, Natalija Nakov, Blagica Manchevska, Packa Antovska, Sonja Ugarkovic, Aneta Dimitrovska |
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| Jazyk: | angličtina |
| Rok vydání: | 2018 |
| Předmět: | |
| Zdroj: | Macedonian Journal of Chemistry and Chemical Engineering, Vol 37, Iss 2, Pp 111-125 (2018) |
| Druh dokumentu: | article |
| ISSN: | 1857-5552 1857-5625 |
| DOI: | 10.20450/mjcce.2018.1471 |
| Popis: | This study involved the optimization of experimental conditions for the forced degradation of atorvastatin employing the experimental design (DoE) approach, as a scientific multifactorial strategy. Using 2n full factorial design, stress conditions of oxidative, hydrolytic and thermal degradation were optimized to obtain a targeted level of atorvastatin degradation. Atorvastatin and all related and degradation products were separated on Poroshell 120 EC C18 50 ´ 3.0 mm 2.7 μm, using 10 mM ammonium formate and acetonitrile as mobile phases in the gradient mode. The impurity structures were confirmed by the direct hyphenation of a liquid chromatograph to an ion trap mass spectrometer with a heated electrospray ionization interface. This study highlights the multifold benefits of implementing the DoE concept, which provides a better understanding of the significant factors responsible for degradation and ensures a successful way to achieve degradation, thereby replacing the trial and error approach used in conventional forced degradation studies. |
| Databáze: | Directory of Open Access Journals |
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