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Development of a unified reversed-phase HPLC method for efficient determination of EP and USP process-related impurities in celecoxib using analytical quality by design principles [Elektronski vir]Tome, Tim ; Časar, Zdenko ; Obreza, AlešThis article presents the development of a reversed-phase (RP) high-performance liquid chromatographic (HPLC) method for determination of process-related impurities in a celecoxib drug substance ... following Analytical Quality by Design (AQbD) principles. The method from European Pharmacopeia (EP) for celecoxib drug substance does not sufficiently separate celecoxib from its EP impurity B because the system suitability criterion is not achieved (resolution NLT 1.8). The same issue was observed with the proposed method from United States Pharmacopeia (USP) for celecoxib capsules, where EP impurity A elutes under the main peak. A new HPLC method was developed that eliminates the disadvantages of the two pharmacopeial methods and is capable of efficiently separating and determining all seven impurities listed in EP and the proposed USP monographs. The development of a new HPLC method started with method scouting, in which various C18 and phenyl stationary phases were tested. Improved selectivity was obtained only with a chiral stationary phase. An immobilized Chiralpak IA-3 column used in RP mode turned out to be the most appropriate for method optimization. The ratio of acetonitrile in the mobile phase, flow rate, and column temperature were recognized as critical method parameters (CMPs) and were further investigated using a central composite face response-surface design. A multiple linear regression (MLR) method was applied to fit the mathematical models on the experimental data to determine factor'response relationships. The models created show adequate fit and good prediction abilities. The Monte Carlo simulation method was used to establish the design space. The method developed was verified in terms of precision, sensitivity, accuracy, and linearity, and the results showed that the new method is suitable for determination of seven process-related impurities of celecoxib.Vir: Molecules [Elektronski vir]. - ISSN 1420-3049 (Vol. 25, no. 4, 2020, str. 1-18)Vrsta gradiva - e-članekLeto - 2020Jezik - angleškiCOBISS.SI-ID - 4882289
Avtor
Tome, Tim |
Časar, Zdenko |
Obreza, Aleš
Teme
Tekočinska kromatografija |
Farmakopeja |
Farmacevtska kemija |
RP-HPLC |
AQbD |
HPLC method development |
HPLC method optimization |
pharmacopeia |
celecoxib |
celekoksib |
farmakopeja
Vnos na polico
Trajna povezava
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Faktor vpliva
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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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Tome, Tim | |
Časar, Zdenko | 19281 |
Obreza, Aleš | 19061 |
Vir: Osebne bibliografije
in: SICRIS
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