Determinação de sibutramina em formas farmacêuticas através de espectroscopia no infravermelho com refletância difusa e métodos de calibração multivariada

Química Nova

Daniela Florencio Maluf²  Roberto Pontarolo²  Gilcélia A. Cordeiro¹  Noemi Nagata¹  Patricio Peralta-zamora¹ 

[1] ,Universidade Federal do Paraná Departamento de Farmácia Curitiba PR ,Brasil

关键词: sibutramine;    DRIFTS;    multivariate calibration;   

DOI  :  10.1590/S0100-40422010000300031

来源: SciELO

【 摘 要 】

The goal of this work is the development and validation of an analytical method for fast quantification of sibutramine in pharmaceutical formulations, using diffuse reflectance infrared spectroscopy and partial least square regression. The multivariate model was elaborated from 22 mixtures containing sibutramine and excipients (lactose, microcrystalline cellulose, colloidal silicon dioxide and magnesium stearate) and using fragmented (750-1150/ 1350-1500/ 1850-1950/ 2600-2900 cm-1) and smoothing spectral data. Using 10 latent variables, excellent predictive capacity were observed in the calibration (n=20, RMSEC=0.004, R= 0.999) and external validation (n=5, RMSEC= 9.36, R=0.999) phases. In the analysis of synthetic mixtures the precision (SD=3,47%) was compatible with the rules of the Agencia Nacional de Vigilância Sanitária (ANVISA-Brazil). In the analysis of commercial drugs good agreement was observed between spectroscopic and chromatographic methods.

【 授权许可】

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