Comparison of Fluconazol capsules dissolution profiles

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.