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Development of an analytical method for determination of related substances and degradation products of cabotegravir using analytical quality by design principles [Elektronski vir]Kovač, Lidija, farmacevtka ...Cabotegravir is one of the newly approved human immunodeficiency virus (HIV) integrase enzyme inhibitors used for the prevention and treatment of HIV infection. It is the first approved long-acting ... injectable antiretroviral therapy for HIV and is also very effective in combination with rilpivirine, a non-nucleoside reverse transcriptase inhibitor. Therefore, future drug development involving cabotegravir can be expected. We developed an ultrahigh performance liquid chromatography (UHPLC) method compatible with mass spectrometry for the determination of eight cabotegravir impurities. The described method is able to differentiate cabotegravir and its related substances as well as its degradation products. Analytical quality by design principles were used for method development. The method is robust within the defined method operable design region: flow rate = 0.32–0.40 mL/min; column temperature = 30–40 °C; pH of mobile phase A = 3.25–3.75, and the final percent of acetonitrile in gradient = 50.0–60.0%. Inside the method operable design region, a working optimal point was selected: pump flow rate = 0.36 mL/min; column temperature = 35 °C; pH of mobile phase A = 3.5, and final percent of acetonitrile in gradient = 55%. Method validation was performed, and the following parameters were verified: accuracy, repeatability, linearity, response factors, detection limit, and quantification limit. All method validation results were within selected criteria. The presented method could be used for the development of new pharmaceutical products based on cabotegravir.Vir: ACS omega [Elektronski vir]. - ISSN 2470-1343 (iss. 10, Vol. 7, 2022, str. 8896–8905)Vrsta gradiva - e-članek ; neleposlovje za odrasleLeto - 2022Jezik - angleškiCOBISS.SI-ID - 100925955
Avtor
Kovač, Lidija, farmacevtka |
Časar, Zdenko |
Trdan Lušin, Tina |
Roškar, Robert, 1975-
Teme
Zdravila |
Topila |
nečistoče |
razgradnja |
fenili |
kromatografija |
impurities |
degradation |
phenyls |
chromatography |
Solvents
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Leto | Faktor vpliva | Izdaja | Kategorija | Razvrstitev | ||||
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JCR | SNIP | JCR | SNIP | JCR | SNIP | JCR | SNIP |
Baze podatkov, v katerih je revija indeksirana
Ime baze podatkov | Področje | Leto |
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Povezave do osebnih bibliografij avtorjev | Povezave do podatkov o raziskovalcih v sistemu SICRIS |
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Kovač, Lidija, farmacevtka | ![]() |
Časar, Zdenko | 19281 |
Trdan Lušin, Tina | 30817 |
Roškar, Robert, 1975- | 23549 |
Vir: Osebne bibliografije
in: SICRIS
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