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An eco-friendly strategy, using on-line monitoring and dilution coupled to a second-order chemometric method, for the construction of dissolution curves of combined pharmaceutical associations.
Calvo, Natalia L; Maggio, Rubén M; Kaufman, Teodoro S.
Afiliação
  • Calvo NL; Pharmaceutical Analysis, Department of Organic Chemistry, School of Pharmaceutical and Biochemical Sciences, National University of Rosario and Institute of Chemistry of Rosario (IQUIR, CONICET-UNR), Suipacha 531, Rosario S2002LRK, Argentina.
  • Maggio RM; Pharmaceutical Analysis, Department of Organic Chemistry, School of Pharmaceutical and Biochemical Sciences, National University of Rosario and Institute of Chemistry of Rosario (IQUIR, CONICET-UNR), Suipacha 531, Rosario S2002LRK, Argentina.
  • Kaufman TS; Pharmaceutical Analysis, Department of Organic Chemistry, School of Pharmaceutical and Biochemical Sciences, National University of Rosario and Institute of Chemistry of Rosario (IQUIR, CONICET-UNR), Suipacha 531, Rosario S2002LRK, Argentina. Electronic address: kaufman@iquir-conicet.gov.ar.
J Pharm Biomed Anal ; 89: 213-20, 2014 Feb.
Article em En | MEDLINE | ID: mdl-24291800
A simple, precise, economic and minimally operator-dependent method was developed under green analytical chemistry principles, for the simultaneous construction of the dissolution curves of a pharmaceutical association in short time and without employing organic solvents, allowing important savings of labor and resources. The carvedilol (CAR) and hydrochlorothiazide (HCT) combined formulation was employed as a model. The method (OD/UV-MCR) involves on-line sample dilution (OD) and UV detection of the analytes, coupled to multivariate curve resolution with alternating least squares (MCR-ALS). OD/UV-MCR proved to be robust and was successfully validated in accordance to ICH guidelines, fulfilling acceptance criteria for specificity (r(2) of spectral correlation>0.950), linearity [r>0.999 (N=25) in the ranges 1.00-31.1mg l(-1) and 0.51-15.2mg l(-1) for CAR and HCT, respectively] and precision (RSD<2%). Accuracy was assessed by point-to-point comparison between the dissolution profiles furnished by the proposed method with those provided by HPLC analysis, evidencing the usefulness of this monitoring system. In addition, OD/UV-MCR was successfully employed for the comparative analysis of three lots of commercial formulations of the CAR-HCT pharmaceutical association, belonging to a couple of different brands, employing Moore and Flanner's f2 similarity indicator.
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Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Propanolaminas / Carbazóis / Química Farmacêutica / Hidroclorotiazida Tipo de estudo: Prognostic_studies / Risk_factors_studies Idioma: En Revista: J Pharm Biomed Anal Ano de publicação: 2014 Tipo de documento: Article País de afiliação: Argentina País de publicação: Reino Unido

Texto completo: 1 Coleções: 01-internacional Base de dados: MEDLINE Assunto principal: Propanolaminas / Carbazóis / Química Farmacêutica / Hidroclorotiazida Tipo de estudo: Prognostic_studies / Risk_factors_studies Idioma: En Revista: J Pharm Biomed Anal Ano de publicação: 2014 Tipo de documento: Article País de afiliação: Argentina País de publicação: Reino Unido