Abstract:
Introduction. The dissolution test is the most used physico- chemical test in the evaluation of
the quality of the medicinal product to assess the in vitro-in vivo correlation. In the development
of drug formulation, is it used to select optimal composition, study of stability and physicochemical
parameters required in the technological process, and in quality control for verifying
the reproducibility of in vitro release of series launched on the pharmaceutical market.
Aim of the study. is to investigate the dissolution profile of Fluconazole-RNP 50 mg capsules
compared to another recognized manufacturer (Mycosyst 50 mg Gedeon Richter Ltd. (Hungary)
capsules.
Materials and methods. "Shimadzu" HPLC Chromatograph with RID-10A Detector; electronic
analytical balance; pH meter Consort C861; Fuconazole-RNP and Mycosyst Gedeon Richter
capsules; acetonitrile; methanol.
Results. The dissolution test demonstrated the similarity of the dissolution profiles of the
compared products.
Conclusions. All media used to compare the dissolution profiles of fluconazole capsules in the
dissolution test show that the similarity factor (f2) is at least 50, which demonstrates the
similarity of the fluconazole-RNP bioavailability compared to Mycosyst.
Description:
Department of Pharmaceutical and Toxicological Chemistry, The Scientific Center of drug,
Nicolae Testemitanu State University of Medicine and Pharmacy of the Republic of Moldova
