title: Enantioseparation of phenotiazines by affinity electrokinetic chromatography using human serum albumin as chiral selector: application to enantiomeric quality control in pharmaceutical formulations.
abstract: 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.
authors: Departamento de Química Analítica, Facultat de Farmacia, Universitat de València, C/Vicent Andrés Estellés s/n, E-46100 Burjassot, Valencia, Spain.
authors: María Amparo
authors: MA
authors: Martínez-Gómez
authors: Salvador
authors: S
authors: Sagrado
authors: Rosa María
authors: RM
authors: Villanueva-Camañas
authors: Maria José
authors: MJ
authors: Medina-Hernández
mesh_terms: 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
chemical_list: D004364:Pharmaceutical Preparations; D010640:Phenothiazines; D012709:Serum Albumin