Bioanalytical Method Development and Validation of Griseofulvin Nanoparticles using RP-HPLC

Abstract

Objective: To prepare griseofulvin nanoparticles by emulsification solvent evaporation method and to evaluate its physical characters and bioavailability-bioequivalence properties.Methods: Bioanalytical method development of griseofulvin nanoparticle by using RP-HPLC method. The particle size and zeta potential was determined by scanning electron microscopy and Zetasizer, respectively and in vitro study was done by ultra centrifugation method. The release kinetics was also studied by fitting into few mathematical models. The bioanalytical study in rats was carried out.Results: The in vitro release studies showed that after the initial burst, all the drug-loaded batches provided can be substantiated by the fact that release profile of drug molecules, irrespective of their chemical nature was almost linear with time. For the polymer like PMMA, drug particles present in the surface of matrix is initially released into medium generating many pores and cracks which facilitate further drug release. Bioavailability-bioequivalence studies showed that the release of drug from nanoparticles was diffusion-controlled, and the mechanism of drug release was Fickian. The bio-distribution of these particles after intravenous injection in rats showed that of griseofulvin nanoparticles containing PMMA altered the bio-distribution pattern.Conclusion: Griseofulvin nanoparticles are proven to be an optimized drug delivery system with potential significance as an antifungal medicament. The preparation showed optimal bioavailability-bioequivalence characteristics in a rat model.

Keywords: Bioanalytical method development; Bioavailability; Griseofulvin; HPLC; Nanoparticles