RESUMO
A new chromatographic method for the enantioseparation and the determination of (-)-trans-paroxetine and (+)-trans-paroxetine has been developed with the aid of amylose ovomucoid-based chiral stationary phase. The method is faster and five times more sensitive than procedures recommended previously: limit of detection and limit of quantification are 5 and 16 ng/mL, respectively [modified (Ferretti et al. in J Chromatogr B 710:157-164, 1998): 20 and 60 ng/mL]. It was carefully validated and applied for the determination of (-)-trans-paroxetine and (+)-trans-paroxetine in Parogen (Mc Dermott Laboratories Ltd.) and Xetanor (Actavis) coated tablets.
Assuntos
Amilose/química , Química Farmacêutica/métodos , Ovomucina/química , Paroxetina/análise , Paroxetina/química , Tecnologia Farmacêutica/métodos , Antidepressivos de Segunda Geração/análise , Antidepressivos de Segunda Geração/química , Técnicas de Química Analítica , Cromatografia , Cromatografia Líquida de Alta Pressão , Humanos , Limite de Detecção , Valores de Referência , Reprodutibilidade dos Testes , Estereoisomerismo , ComprimidosRESUMO
New chromatographic method for the enantioseparation of (R,S)-tamsulosin and the determination of (R)- and (S)-tamsulosin was developed with the aid of amylose tris(3,5-dimethylphenylcarbamate) stationary phase. The method was compared to the known procedure for tamsulosin enantioseparation on cellulose tris(3,5-dimethylphenyl carbamate). Careful validation of both methods allowed to prove advantages of the new procedure: significantly better resolution as well as twice better sensitivity. The method was applied to quantification of (R)- and (S)-tamsulosin contents in prolonged release Apo-Tamis 0.4 mg hard capsules (Apotex Europe B.V) and Omnic Ocas 0.4 mg coated tablets (Astellas).
