Abstract

CALZADILLA AGUIAR, Wendy et al. Validation of a quality control method of a new 2 % miconazole nitrate cream. Rev Cubana Farm [online]. 2013, vol.47, n.4, pp. 455-467. ISSN 0034-7515.

Objective: to validate a quality control method for a 2% new miconazole nitrate cream. Methods: the validation was made following the category I parameters and taking into account the methodology and acceptance criteria in force in Cuba. Once validated, the analysis of the three batches was applied on pilot scale. Results: the results were satisfactory since they fulfilled all the set parameters. The method was linear, accurate and precise in the 10-30 mg/g range. there was no interference from any of the components of the new formulation. The batches presented correct dosing, without any statistically significant differences between replicas and analyzed batches. Conclusions: the evaluated method proved to be valid for the stated purpose.

Keywords : miconazole nitrate; quality control; two-phase system volumetry; validation; cream.

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