Revista Cubana de Farmacia
versión On-line ISSN 1561-2988
CUEVAS VALDESPINO, Matilde et al. Development of a HPLC-IR method for determination of residual ethanol in vaccine. Rev Cubana Farm [online]. 2009, vol.43, n.2, pp. 0-0. ISSN 1561-2988.
Active pharmaceutical ingredients of Cuban anti-meningococcal vaccine VA-MENGOC-BCTM (vesicles of purified external membranes of Neisseria meningitidis, B serum-group, and purified capsular polysaccharide of Neisseria meningitidis, serum-group C) are stored in ethanol, thus that such vaccine has residual ethanol content, of which real concentration is not known just now. International regulations propose that the biopharmaceutical products and its active pharmaceutical ingredients must to have well defined all impurities, thus, the aim of present papers was to develop an ethanol assessment method by liquid high performance-refraction index chromatography to these aims and its comparison with a frequent used method to quantify this solvent, like in the case of gas chromatography. Method assessed was very useful and with a good robustness for determination of this organic solvent in this anti-meningococcal vaccine. There were not statistically significant differences among results obtained with assessment of the same samples of vaccine by both chromatographic methods (high resolution liquid and gas), indicating possibility of high performance liquid chromatography use in substitution of the gas one for this determination.
Palabras llave : Ethanol; gas-chromatography; high performance liquid-chromatography (HPLC); impurity.