Abstract

PEREZ NAVARRO, Maikel; RODRIGUEZ HERNANDEZ, Yaslenis  and  SUAREZ PEREZ, Yania. Validation of the quality control methods for active ingredients of Fungirex cream. Rev Cubana Farm [online]. 2014, vol.48, n.2, pp. 213-224. ISSN 0034-7515.

Introduction: Fungirex cream is a two-drug product, that is, undecylenic acid and zinc undecylenate over a suitable basis. Since this is a product not documented in the official monographs of the pharmacopeae, simple analytical methods were suggested for quantitation of analytes of interest in the cream, which are useful for release of newly prepared cream batches. Objective: to validate two volumetric methods for the quality control of active ingredients in Fungirex cream. Methods: a direct neutralization volumetric method was suggested to quantitate undecylenic acid after the analyte extraction and EDTA complexometry for zinc undecylenate . According to the classification of both methods in the category I, they were validated through the parameters specificity, linearity, accuracy, precision and range. Results: the non-interference of the rest of the matrix components was corroborated. The set acceptance criteria for linearity, accuracy and precision were satisfactorily met for the two study methods, so they were valid in the 50-150 % range (neutralization volumetry method: 25.6-76.8 mg/g and complexometry method 111.1-333,3 mg/g). Conclusions: the suggested volumetric methods were linear, specific, precise, and accurate for the quality control of Fungirex cream based on the undecylenic acid and zinc undecylenate content.

Keywords : validación; complejometría; volumetría de neutralización; ácido undecilénico; undecilenato de zinc; crema; validation; complexometry; neutralization volumetry; undecylenic acid; zinc undecylenate; cream.

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