DETERMINATION OF SIBUTRAMINE IN PHARMACEUTICAL FORMULATIONS BY DIFFUSE REFLECTANCE INFRARED SPECTROSCOPY AND MULTIVARIATE CALIBRATION METHODS.

作者：Maluf Daniela Florencio^*; Pontarolo Roberto; Cordeiro Gicelia A; Nagata Noemi; Peralta Zamora Patricio

来源：Quimica Nova, 2010, 33(3): 649-652.

DOI：10.1590/S0100-40422010000300031

• sibutramine
• DRIFTS
• multivariate calibration

DETERMINATION OF SIBUTRAMINE IN PHARMACEUTICAL FORMULATIONS BY DIFFUSE REFLECTANCE INFRARED SPECTROSCOPY AND MULTIVARIATE CALIBRATION METHODS. 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=0.9991 and external validation (n=5. RIVISEC=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 Vigilancia Sanitaria (ANVISA-Brazil). In the analysis of commercial drugs good agreement was observed between spectroscopic and chromatographic methods.

• 出版日期2010