FRINK Linked Data Fragments server

Matches in SemOpenAlex for { <https://semopenalex.org/work/W2015327507> ?p ?o ?g. }

• W2015327507 endingPage "185" @default.
• W2015327507 startingPage "177" @default.
• W2015327507 abstract "Quality by design (QbD) concepts, in accordance with International Conference on Harmonisation Pharmaceutical Development guideline Q8(R2), represent an innovative strategy for the development of analytical methods. In this paper QbD principles have been comprehensively applied in the set-up of a capillary electrophoresis method aimed to quantify enantiomeric impurities. The test compound was the chiral drug substance levosulpiride (S-SUL) and the developed method was intended to be used for routine analysis of the pharmaceutical product. The target of analytical QbD approach is to establish a design space (DS) of critical process parameters (CPPs) where the critical quality attributes (CQAs) of the method have been assured to fulfil the desired requirements with a selected probability. QbD can improve the understanding of the enantioseparation process, including both the electrophoretic behavior of enantiomers and their separation, therefore enabling its control. The CQAs were represented by enantioresolution and analysis time. The scouting phase made it possible to select a separation system made by sulfated-β-cyclodextrin and a neutral cyclodextrin, operating in reverse polarity mode. The type of neutral cyclodextrin was included among other CPPs, both instrumental and related to background electrolyte composition, which were evaluated in a screening phase by an asymmetric screening matrix. Response surface methodology was carried out by a Doehlert design and allowed the contour plots to be drawn, highlighting significant interactions between some of the CPPs. DS was defined by applying Monte-Carlo simulations, and corresponded to the following intervals: sulfated-β-cyclodextrin concentration, 9-12 mM; methyl-β-cyclodextrin concentration, 29-38 mM; Britton-Robinson buffer pH, 3.24-3.50; voltage, 12-14 kV. Robustness of the method was examined by a Plackett-Burman matrix and the obtained results, together with system repeatability data, led to define a method control strategy. The method was validated and was finally applied to determine the enantiomeric purity of S-SUL in pharmaceutical dosage forms." @default.
• W2015327507 created "2016-06-24" @default.
• W2015327507 creator A5024762484 @default.
• W2015327507 creator A5030143622 @default.
• W2015327507 creator A5035696172 @default.
• W2015327507 creator A5051454325 @default.
• W2015327507 creator A5067450827 @default.
• W2015327507 date "2015-02-01" @default.
• W2015327507 modified "2023-10-01" @default.
• W2015327507 title "Quality by design in the chiral separation strategy for the determination of enantiomeric impurities: Development of a capillary electrophoresis method based on dual cyclodextrin systems for the analysis of levosulpiride" @default.
• W2015327507 cites W135697628 @default.
• W2015327507 cites W139217710 @default.
• W2015327507 cites W1584512000 @default.
• W2015327507 cites W184480178 @default.
• W2015327507 cites W1964974125 @default.
• W2015327507 cites W1973187970 @default.
• W2015327507 cites W1977202534 @default.
• W2015327507 cites W1979103340 @default.
• W2015327507 cites W1984103973 @default.
• W2015327507 cites W1988514367 @default.
• W2015327507 cites W1990017791 @default.
• W2015327507 cites W2000945306 @default.
• W2015327507 cites W2004946103 @default.
• W2015327507 cites W2008052093 @default.
• W2015327507 cites W2015340411 @default.
• W2015327507 cites W2016095538 @default.
• W2015327507 cites W2016390185 @default.
• W2015327507 cites W2020149277 @default.
• W2015327507 cites W2022439150 @default.
• W2015327507 cites W2033083597 @default.
• W2015327507 cites W2034171014 @default.
• W2015327507 cites W2035352793 @default.
• W2015327507 cites W2036705824 @default.
• W2015327507 cites W2048381255 @default.
• W2015327507 cites W2049509410 @default.
• W2015327507 cites W2051994928 @default.
• W2015327507 cites W2052558644 @default.
• W2015327507 cites W2053884177 @default.
• W2015327507 cites W2054680364 @default.
• W2015327507 cites W2060885878 @default.
• W2015327507 cites W2061244298 @default.
• W2015327507 cites W2061767150 @default.
• W2015327507 cites W2062299510 @default.
• W2015327507 cites W2067942772 @default.
• W2015327507 cites W2068461518 @default.
• W2015327507 cites W2068527879 @default.
• W2015327507 cites W2071863555 @default.
• W2015327507 cites W2072917861 @default.
• W2015327507 cites W2073155431 @default.
• W2015327507 cites W2090951137 @default.
• W2015327507 cites W2110262408 @default.
• W2015327507 cites W2111084564 @default.
• W2015327507 cites W2122804828 @default.
• W2015327507 cites W2128938134 @default.
• W2015327507 cites W2167960657 @default.
• W2015327507 cites W2405612468 @default.
• W2015327507 cites W2775707942 @default.
• W2015327507 cites W74876498 @default.
• W2015327507 cites W2075171858 @default.
• W2015327507 cites W95202475 @default.
• W2015327507 doi "https://doi.org/10.1016/j.chroma.2014.12.065" @default.
• W2015327507 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/25582483" @default.
• W2015327507 hasPublicationYear "2015" @default.
• W2015327507 type Work @default.
• W2015327507 sameAs 2015327507 @default.
• W2015327507 citedByCount "58" @default.
• W2015327507 countsByYear W20153275072015 @default.
• W2015327507 countsByYear W20153275072016 @default.
• W2015327507 countsByYear W20153275072017 @default.
• W2015327507 countsByYear W20153275072018 @default.
• W2015327507 countsByYear W20153275072019 @default.
• W2015327507 countsByYear W20153275072020 @default.
• W2015327507 countsByYear W20153275072021 @default.
• W2015327507 countsByYear W20153275072022 @default.
• W2015327507 countsByYear W20153275072023 @default.
• W2015327507 crossrefType "journal-article" @default.
• W2015327507 hasAuthorship W2015327507A5024762484 @default.
• W2015327507 hasAuthorship W2015327507A5030143622 @default.
• W2015327507 hasAuthorship W2015327507A5035696172 @default.
• W2015327507 hasAuthorship W2015327507A5051454325 @default.
• W2015327507 hasAuthorship W2015327507A5067450827 @default.
• W2015327507 hasConcept C147789679 @default.
• W2015327507 hasConcept C178790620 @default.
• W2015327507 hasConcept C185592680 @default.
• W2015327507 hasConcept C187530423 @default.
• W2015327507 hasConcept C204320433 @default.
• W2015327507 hasConcept C2779433975 @default.
• W2015327507 hasConcept C2780449318 @default.
• W2015327507 hasConcept C2900643 @default.
• W2015327507 hasConcept C43617362 @default.
• W2015327507 hasConcept C486523 @default.
• W2015327507 hasConceptScore W2015327507C147789679 @default.
• W2015327507 hasConceptScore W2015327507C178790620 @default.
• W2015327507 hasConceptScore W2015327507C185592680 @default.
• W2015327507 hasConceptScore W2015327507C187530423 @default.
• W2015327507 hasConceptScore W2015327507C204320433 @default.
• W2015327507 hasConceptScore W2015327507C2779433975 @default.
• W2015327507 hasConceptScore W2015327507C2780449318 @default.

• next