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
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...
| Autores: | , , |
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| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2014 |
| País: | Argentina |
| Institución: | Consejo Nacional de Investigaciones Científicas y Técnicas |
| Repositorio: | CONICET Digital (CONICET) |
| Idioma: | inglés |
| OAI Identifier: | oai:ri.conicet.gov.ar:11336/5982 |
| Acceso en línea: | http://hdl.handle.net/11336/5982 |
| Access Level: | acceso abierto |
| Palabra clave: | Mcr-Als Green Analytical Chemistry Simultaneous Dissolution Profiles https://purl.org/becyt/ford/1.4 https://purl.org/becyt/ford/1 |
| Sumario: | 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 (r2 of spectral correlation > 0.950), linearity [r > 0.999 (N = 25) in the ranges 1.00–31.1 mg l−1 and 0.51–15.2 mg 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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