Resumen

VICENTE MURILLO, Roxana et al. FATTY ALCOHOLS DETERMINATION METHOD FOR QUALITY CONTROL AND STABILITY STUDIES OF A NEW SKIN PROTECTIVE CREAM. Rev. CENIC Cienc. Quím. [online]. 2022, vol.53, n.2, pp. 281-287.  Epub 15-Jul-2022. ISSN 2221-2442.

A cream with 1-octacosanol and 1-triacontanol was recently developed for the treatment of skin damage and conditions, the effect of which is due to the anti-inflammatory and antioxidant properties of these alcohols. Current regulations require duly validated methodologies for the determination of the active ingredients in all finished forms, so it was developed and validated an analytical method by gas chromatography for the determination of 1-octacosanol and 1 -triacontanol in the new cream. The alcohols were extracted with chloroform and analyzed as trimethylsilyl derivatives using a capillary column, and 1-eicosanol as internal standard. The specificity study showed that the determination of alcohols is not interfered by the internal standard or by the other components of the cream, and that no new chromatographic peaks appear in the analysis of samples subjected to stress conditions. The method was found to be linear (correlation coefficient = 1.0) and unbiased (confidence interval of the intercept included zero), as well as exact (mean recovery without significant differences with 100%) in an interval of 50 -150% of the nominal concentration. The repeatability and intermediate precision, at the nominal concentration, met the acceptance criteria (CV < 5.7%), and the factors analyst and day of analysis did not significantly influence the dispersion of the results, all of which showed that the method is accurate. The method can therefore be used for quality control and cream stability studies.

Palabras clave : alcohols; creams; gas chromatography; validation.