• Something wrong with this record ?

Enantioseparation and impurity determination of ambrisentan using cyclodextrin-modified micellar electrokinetic chromatography: Visualizing the design space within quality by design framework

S. Orlandini, B. Pasquini, C. Caprini, M. Del Bubba, M. Douša, S. Pinzauti, S. Furlanetto,

. 2016 ; 1467 (-) : 363-371. [pub] 20160701

Language English Country Netherlands

Document type Journal Article

Persistent link   https://www.medvik.cz/link/bmc17000243

A capillary electrophoresis method for the simultaneous determination of the enantiomeric purity and of impurities of the chiral drug ambrisentan has been developed following the Quality by Design principles. The selected separation system consisted of a micellar pseudostationary phase made by sodium dodecyl sulphate with the addition of γ-cyclodextrin. The effects of critical process parameters (capillary length, temperature, voltage, borate concentration, pH, sodium dodecyl sulphate concentration, γ-cyclodextrin concentration) on enantioresolution of ambrisentan and analysis time were extensively investigated by multivariate strategies involving a screening phase and Response Surface Methodology. The Design Space was defined with a desired probability level π≥90%, and the working conditions, with the limits of the Design Space, corresponded to the following: capillary length, 64.5cm; temperature, 22°C; voltage, 30kV (26-30kV); background electrolyte, 100mM borate buffer pH 9.20 (8.80-9.60), 100mM sodium dodecyl sulphate, 50mM (43-50mM) γ-cyclodextrin. A Plackett-Burman design was applied for robustness testing, and a method control strategy was established. The method was fully validated according to the International Conference on Harmonisation guidelines and was applied to ambrisentan coated tablets.

References provided by Crossref.org

000      
00000naa a2200000 a 4500
001      
bmc17000243
003      
CZ-PrNML
005      
20170103132946.0
007      
ta
008      
170103s2016 ne f 000 0|eng||
009      
AR
024    7_
$a 10.1016/j.chroma.2016.06.082 $2 doi
024    7_
$a 10.1016/j.chroma.2016.06.082 $2 doi
035    __
$a (PubMed)27425759
040    __
$a ABA008 $b cze $d ABA008 $e AACR2
041    0_
$a eng
044    __
$a ne
100    1_
$a Orlandini, S $u Department of Chemistry "U. Schiff", University of Florence, Via U. Schiff 6, 50019 Sesto Fiorentino, Florence, Italy.
245    10
$a Enantioseparation and impurity determination of ambrisentan using cyclodextrin-modified micellar electrokinetic chromatography: Visualizing the design space within quality by design framework / $c S. Orlandini, B. Pasquini, C. Caprini, M. Del Bubba, M. Douša, S. Pinzauti, S. Furlanetto,
520    9_
$a A capillary electrophoresis method for the simultaneous determination of the enantiomeric purity and of impurities of the chiral drug ambrisentan has been developed following the Quality by Design principles. The selected separation system consisted of a micellar pseudostationary phase made by sodium dodecyl sulphate with the addition of γ-cyclodextrin. The effects of critical process parameters (capillary length, temperature, voltage, borate concentration, pH, sodium dodecyl sulphate concentration, γ-cyclodextrin concentration) on enantioresolution of ambrisentan and analysis time were extensively investigated by multivariate strategies involving a screening phase and Response Surface Methodology. The Design Space was defined with a desired probability level π≥90%, and the working conditions, with the limits of the Design Space, corresponded to the following: capillary length, 64.5cm; temperature, 22°C; voltage, 30kV (26-30kV); background electrolyte, 100mM borate buffer pH 9.20 (8.80-9.60), 100mM sodium dodecyl sulphate, 50mM (43-50mM) γ-cyclodextrin. A Plackett-Burman design was applied for robustness testing, and a method control strategy was established. The method was fully validated according to the International Conference on Harmonisation guidelines and was applied to ambrisentan coated tablets.
650    _2
$a boritany $x chemie $7 D001881
650    _2
$a pufry $7 D002021
650    _2
$a kalibrace $7 D002138
650    12
$a chromatografie micelární elektrokinetická kapilární $x metody $7 D020374
650    _2
$a cyklodextriny $7 D003505
650    _2
$a kontaminace léku $7 D004340
650    _2
$a koncentrace vodíkových iontů $7 D006863
650    _2
$a fenylpropionáty $x analýza $x chemie $7 D010666
650    _2
$a pyridaziny $x analýza $x chemie $7 D011724
650    _2
$a řízení kvality $7 D011786
650    _2
$a reprodukovatelnost výsledků $7 D015203
650    _2
$a dodecylsíran sodný $7 D012967
650    _2
$a stereoizomerie $7 D013237
650    _2
$a tablety $x analýza $7 D013607
655    _2
$a časopisecké články $7 D016428
700    1_
$a Pasquini, B $u Department of Chemistry "U. Schiff", University of Florence, Via U. Schiff 6, 50019 Sesto Fiorentino, Florence, Italy.
700    1_
$a Caprini, C $u Department of Chemistry "U. Schiff", University of Florence, Via U. Schiff 6, 50019 Sesto Fiorentino, Florence, Italy.
700    1_
$a Del Bubba, M $u Department of Chemistry "U. Schiff", University of Florence, Via della Lastruccia 3-13, 50019 Sesto Fiorentino, Florence, Italy.
700    1_
$a Douša, M $u Zentiva, k.s. Praha, a Sanofi Company, U Kabelovny 130, 102 37 Praha 10, Czech Republic.
700    1_
$a Pinzauti, S $u Department of Chemistry "U. Schiff", University of Florence, Via U. Schiff 6, 50019 Sesto Fiorentino, Florence, Italy.
700    1_
$a Furlanetto, S $u Department of Chemistry "U. Schiff", University of Florence, Via U. Schiff 6, 50019 Sesto Fiorentino, Florence, Italy. Electronic address: sandra.furlanetto@unifi.it.
773    0_
$w MED00004962 $t Journal of chromatography. A $x 1873-3778 $g Roč. 1467, č. - (2016), s. 363-371
856    41
$u https://pubmed.ncbi.nlm.nih.gov/27425759 $y Pubmed
910    __
$a ABA008 $b sig $c sign $y a $z 0
990    __
$a 20170103 $b ABA008
991    __
$a 20170103133033 $b ABA008
999    __
$a ok $b bmc $g 1179383 $s 960810
BAS    __
$a 3
BAS    __
$a PreBMC
BMC    __
$a 2016 $b 1467 $c - $d 363-371 $e 20160701 $i 1873-3778 $m Journal of chromatography. A, Including electrophoresis and other separation methods $n J Chromatogr A $x MED00004962
LZP    __
$a Pubmed-20170103

Find record

Citation metrics

Archiving options