Enantioseparation of phenotiazines by affinity electrokinetic chromatography using human serum albumin as chiral selector: application to enantiomeric quality control in pharmaceutical formulations.
Nowadays, there is a special interest within the pharmaceutical laboratories to develop single enantiomer formulations and consequently a need for analytical methods to determine the enantiomeric purity of drugs. The present paper deals with the enantiomeric separation of promethazine and trimeprazine enantiomers by affinity electrokinetic chromatography (AEKC)-partial filling technique using human serum albumin (HSA) as chiral selector. A multivariate optimization of the most critical experimental variables in enantioresolution, running pH, HSA concentration and plug length, is carried out to obtain enantioresolution of promethazine and trimeprazine. The estimated maximum and optimum resolution of trimeprazine and prometazine enantiomers (Rs=1.74 and 2.01, respectively) corresponded to the following experimental conditions: pH 7.5; [HSA] 170 microM and plug length 190 s and pH 7.6; [HSA] 170 microM and plug length 170 s, for trimeprazine and prometazine, respectively. The developed methodologies were applied for the enantiomeric quality control of promethazine and trimeprazine enantiomers in commercially available pharmaceutical formulations. Resolution, accuracy, reproducibility, cost and sample throughput of the proposed methodologies make it suitable for quality control of the enantiomeric composition of promethazine and trimeprazine in pharmaceutical preparations.
Martínez-Gómez
María Amparo
MA
Departamento de Química Analítica, Facultat de Farmacia, Universitat de València, C/Vicent Andrés Estellés s/n, E-46100 Burjassot, Valencia, Spain.
Sagrado
Salvador
S
Villanueva-Camañas
Rosa María
RM
Medina-Hernández
Maria José
MJ
D020374:Chromatography, Micellar Electrokinetic Capillary / Q000379:methods*; D006801:Humans; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D010640:Phenothiazines / Q000737:chemistry / Q000302:isolation & purification*; D011786:Quality Control; D015203:Reproducibility of Results; D012709:Serum Albumin / Q000737:chemistry*; D013237:Stereoisomerism
D004364:Pharmaceutical Preparations; D010640:Phenothiazines; D012709:Serum Albumin