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Chiral recognition of dapoxetine enantiomers with methylated-gamma-cyclodextrin: A validated capillary electrophoresis method

  • Metaadatok
Tartalom: http://dx.doi.org/10.1016/j.jpba.2011.12.032
Archívum: MTA Könyvtár
Gyűjtemény: Status = Published


Type = Article
Cím:
Chiral recognition of dapoxetine enantiomers with methylated-gamma-cyclodextrin: A validated capillary electrophoresis method
Létrehozó:
Neumajer, Gábor
Sohajda, Tamás
Darcsi, András
Tóth, Gergő
Szente, Lajos
Noszál, Béla
Béni, Szabolcs
Dátum:
2012
Téma:
QD Chemistry / kémia
RS Pharmacy and materia medica / gyógyszerészet, gyógyászati eszközök
Tartalmi leírás:
The enantiomers of dapoxetine, a serotonin transporter inhibitor for the treatment of premature ejaculation have been separated by cyclodextrin modified capillary zone electrophoresis using uncoated fused-silica capillary. Over 20 cyclodextrins were screened as chiral selectors, investigating the stability of the inclusion complexes and enantioseparating properties. According to the preliminary experiments as chiral selector randomly methylated-?-cyclodextrin was chosen. The basic chemical and instrumental parameters of enantioseparation as concentration of buffer, chiral selector and organic additive, pH, temperature and applied voltage were optimized afterwards using an orthogonal experimental design. Using this methodology not only the optimal parameter values for chiral separation (15 °C, +15 kV, 70 mM acetate, 20 v/v% MeOH, pH* = 4.5, 3 mM methylated-?-CyD) but also the significance order of factors on resolution was determined. Applying these parameters an optimal resolution of 7.01 was achieved. The optimized method was then validated according to the ICH guideline Q2 (R1) with regard to repeatability, linearity range, LOD, LOQ, accuracy and robustness.
Típus:
Article
PeerReviewed
Formátum:
text
Azonosító:
Neumajer, Gábor and Sohajda, Tamás and Darcsi, András and Tóth, Gergő and Szente, Lajos and Noszál, Béla and Béni, Szabolcs (2012) Chiral recognition of dapoxetine enantiomers with methylated-gamma-cyclodextrin: A validated capillary electrophoresis method. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS, 62. pp. 42-47. ISSN 0731-7085
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