Polysaccharide-based chiral phase under polar organic mode of elution in the determination of the enantiomeric purity of emtricitabine an anti-HIV analogue nucleoside.
This work reports the separation of FTC enantiomers using an amylose tris[(S)-1-phenylethylcarbamate] coated onto APS-Nucleosil (7 microm particle size, 500 A pore size, 20% w/w, 15 x 0.46 cm ID) chiral column under polar organic elution mode. Good enantioselectivity (alpha=1.9) with excellent enantioresolution (R(S)=3.3) was achieved by the use of methanol with 0.02% of triethylamine acetate as mobile phase. The method allows the accurate determination of as low as 0.2% of each enantiomer as an impurity. The validated method proved to be reliable and sensitive for the quantification of both enantiomers as impurity in different batches of emtricitabine and beta-D-(+)-FTC.
Cass
Quezia B
QB
Departamento de Qui;mica-Universidade Federal de São Carlos, Cx. Postal 676, 13560-970 São Carlos, SP, Brazil. quezia@dq.ufscar.br
Watanabe
Cecília S F
CS
Rabi
Jaime A
JA
Bottari
Patrícia Q
PQ
Costa
Marcelo R
MR
Nascimento
Rogério M
RM
Cruz
Jorge E D
JE
Ronald
Robert C
RC
D019380:Anti-HIV Agents / Q000032:analysis* / Q000737:chemistry; D002851:Chromatography, High Pressure Liquid / Q000379:methods; D003841:Deoxycytidine / Q000031:analogs & derivatives* / Q000032:analysis* / Q000737:chemistry; D000068679:Emtricitabine; D009705:Nucleosides / Q000032:analysis / Q000737:chemistry; D011134:Polysaccharides / Q000032:analysis* / Q000737:chemistry; D013237:Stereoisomerism
D019380:Anti-HIV Agents; D009705:Nucleosides; D011134:Polysaccharides; D003841:Deoxycytidine; D000068679:Emtricitabine