Abstract

GARCIA PULPEIRO, Oscar et al. Assessment of chromatographic methods for the chemical stability of a new miconazol nitrate cream. Rev Cubana Farm [online]. 2013, vol.47, n.3, pp.300-314. ISSN 0034-7515.

Objective: to assess the chromatographic methods for the chemical stability of a new 2 % miconazol nitrate cream. Methods: various degradation conditions were firstly used in the raw material miconazole nitrate in order to obtain the possible degradation products of this drug and to evaluate them by thin layer chromatography-based method, which was validated to identify the degradation products in the new cream. The performance of the official method based on high resolution liquid chromatography and reported in British Pharmacopeia 2010 was evaluated, and its selectivity against the possible degradation products were also analyzed. Both chromatographic methods were applied to the analysis of cream samples from the three pilot batches under heat stress for 30 days. Results: the two methods showed high selectivity against excipients and degradation products of the drug. Miconazol nitrate was degraded against acid hydrolysis, thermolysis and photolysis, being the detection limit of 1 µg for the thin layer chromatography. No degradation of the analyte was observed in any of the three analyzed batches according to the qualitative and quantitative results. Conclusions: these methods are valid for the submitted objective, so they may be used in the chemical stability study of 2 % miconazol nitrate creams.

Keywords : miconazol nitrate; cream; thin layer chromatography; high performance liquid chromatography; validation.

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