Calzadilla AW, Rodríguez BW, García PO, Suárez PY, Hernández JME

Language: Spanish
References: 8
Page: 455-467
PDF size: 169.48 Kb.

ABSTRACT

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.

REFERENCES

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