Chemical pharmaceutical analysis of fluconazole and its pharmaceutical speciality capsule

Abstract

Fluconazole is a triazole derivated drug with an antifungal activity which is used in the treatment of a large variety of fungal infections. The objective of this work is to establish parameters for the quality control of fluconazole itself, and the pharmaceutical specialities capsules, for elaboration of a monography for Brazilian Pharmacopeia. The raw material of fluconazol was characterized by the following tests: aspect, solubility and fusion range. The fluconazol impurities can be detected through limit assay of chloride, sulphate, iron, heavy metals, lost on drying and residue on ignition. Among the identification tests this drug can be recognized by chemical reactions of functional groups and instrumental methods. To determine the quantitative value of fluconazol in raw material it was used perchloric acid volumetry in acetic medium and period detection by indicators and ultraviolet spectrophotometry utilizing 0,1 M sodium hydroxide in 261 nm was used. Capsules samples from the analysed were aspect, average weight determination, disintegration, dissolution test and dissolution profile. The determination of drug in capsules by ultraviolet spectrophotometry demonstrated linearity, specificity, precision and accuracy. The lots of C, D, and E laboratories showed similar release profiles demonstrating a homogeneous behaviour. The lots of A and B laboratories did not show homogeneity in dissolution profile when compared to other laboratories.