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Developing an improved UHPLC method for efficient determination of European pharmacopeia process-related impurities in ropinirole hydrochloride using analytical quality by design principles
ID
Tome, Tim
(
Avtor
),
ID
Obreza, Aleš
(
Avtor
),
ID
Časar, Zdenko
(
Avtor
)
PDF - Predstavitvena datoteka,
prenos
(3,96 MB)
MD5: 8BCCA261012968BF523C12BE46B40434
URL - Izvorni URL, za dostop obiščite
https://www.mdpi.com/1420-3049/25/11/2691
Galerija slik
Izvleček
This article presents the development of a reversed-phase ultra-high-performance liquid chromatographic method for determining process-related impurities in ropinirole hydrochloride drug substance applying the analytical quality by design approach. The current pharmacopeial method suffers from selectivity issues due to two coelutions of two pairs of impurities. The development of a new method began with preliminary experiments, based on which the Acquity UPLC BEH C8 was selected as the most appropriate column. The effects of six different critical method parameters (CMPs) were then investigated using a fractional factorial screening design. Column temperature, the ratio of methanol in mobile phase B, and gradient slope turned out to be highly significant CMPs in achieving critical resolutions, and they were further evaluated using a central composite face-centered response-surface design. Mathematical models were created by applying a multiple linear regression method. Based on the elution order of an unknown degradation impurity and impurity C, two design spaces were established, and for each design space an optimal combination of CMPs was determined. The method developed was validated for precision, accuracy, linearity, and sensitivity, and it was proven suitable for determining nine process-related impurities of ropinirole.
Jezik:
Angleški jezik
Ključne besede:
AQbD
,
UHPLC
,
method development
,
method optimization
,
design of experiments
,
pharmacopeia
,
ropinirole hydrochloride
Vrsta gradiva:
Članek v reviji
Tipologija:
1.01 - Izvirni znanstveni članek
Organizacija:
FFA - Fakulteta za farmacijo
Status publikacije:
Objavljeno
Različica publikacije:
Objavljena publikacija
Leto izida:
2020
Št. strani:
20 str.
Številčenje:
Vol. 25, iss. 11, art. 2691
PID:
20.500.12556/RUL-133869
UDK:
615.4:615.11:54
ISSN pri članku:
1420-3049
DOI:
10.3390/molecules25112691
COBISS.SI-ID:
19106563
Datum objave v RUL:
17.12.2021
Število ogledov:
831
Število prenosov:
153
Metapodatki:
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Objavi na:
Gradivo je del revije
Naslov:
Molecules
Skrajšan naslov:
Molecules
Založnik:
MDPI
ISSN:
1420-3049
COBISS.SI-ID:
18462981
Licence
Licenca:
CC BY 4.0, Creative Commons Priznanje avtorstva 4.0 Mednarodna
Povezava:
http://creativecommons.org/licenses/by/4.0/deed.sl
Opis:
To je standardna licenca Creative Commons, ki daje uporabnikom največ možnosti za nadaljnjo uporabo dela, pri čemer morajo navesti avtorja.
Začetek licenciranja:
10.06.2020
Sekundarni jezik
Jezik:
Slovenski jezik
Ključne besede:
farmacevtska kemija
,
farmakopeja
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