Abstract

SUAREZ PEREZ, Yania et al. Development and validation of analytical methods for quality control of Micocilen powder. Rev Cubana Farm [online]. 2011, vol.45, n.2, pp. 190-204. ISSN 1561-2988.

The undecylenic acid (Micocilen) is a drug in powder presentation containing two active pharmaceutical ingredients: undecylenic acid and zinc undecylenate. By its fungistatic action becames a first line product in Cuba because of mycoses are typical of wet and warm climates. Development and validation of two analytical methods for the quality control on the base of the quantification of each symbol present in the formula. Volumetric techniques were selected by aqueous neutralization and complexometric. Results were satisfactory since in both cases an appropriate specificity, linearity, accuracy, precision and robustness were obtained. Methods proposed were compared to those previously applied obtaining more reliable results, according to results of analytical analysis applied, without significant differences among replica of a same batch.

Keywords : Undecylenic acid; zinc undecylenate; neutralization volumetry; complexometric; quality control; validation.

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