[Capillary electrochromatography for chiral separation and purity testing of pharmaceutical drug substances].
Chiral separation of D,L-Norgestrel was successfully performed by cyclodextrin-modified capillary electrochromatographic (CEC) method. Optimized CEC conditions for purity testing were achieved: Hypersil C-18 packed capillary and 10 mM 2-[N-morpholino]-ethanesulfonic acid buffer (MES) and 40 v/v % methanol as background electrolyte containing 10 mM gamma-cyclodextrin at pH = 5.5. The resolution was found to be strongly dependent on the concentration of chiral selector gamma-cyclodextrin, applied voltage and temperature of the capillary. Our results represent a simple, fast and reproducible method for the separation of D,L-Norgestrel and purity testing of D-Norgestrel. It can be concluded that cyclodextrin modified HPLC, HPCE and CEC offer inexpensive, attractive and reliable chiral separation methods.
Gazdag
Mária
M
Richter Gedeon Vegyészeti Gyár Rt., Budapest, Pf.: 27.-1475.
Takács
Tímea
T
Szóllósi
Eva
E
D003505:Cyclodextrins; D004563:Electrochemistry; D019075:Electrophoresis, Capillary / Q000379:methods; D007202:Indicators and Reagents; D009644:Norgestrel / Q000737:chemistry / Q000302:isolation & purification; D004364:Pharmaceutical Preparations / Q000737:chemistry / Q000302:isolation & purification* / Q000592:standards; D013237:Stereoisomerism; D013816:Thermodynamics; D047408:gamma-Cyclodextrins
D003505:Cyclodextrins; D007202:Indicators and Reagents; D004364:Pharmaceutical Preparations; D047408:gamma-Cyclodextrins; D009644:Norgestrel; C023792:gamma-cyclodextrin