Abstract

METHOD DEVELOPMENT AND VALIDATION FOR THE DETERMINATION OF RESIDUAL SOLVENTS IN OPHTHALMIC NANOPARTICLE SUSPENSION

Swarnali DasPaul*, Rupa Mazumder, Snehendu Bhattacharya, Arvind Kumar Jha.

ABSTRACT

Eye is a very subtle organ. Thus presence of residual organic solvents in ophthalmic dosage forms may become injurious. However, detection of residual solvents in pharmaceutical formulations is mandatory as per Good Manufacturing Practice guidelines. Our aim was to develop a method for determination of residual solvents for an already developed ophthalmic nanoparticle suspension. For this purpose gas chromatography with a head-space injection system was used. The developed nanoparticle suspension was manufactured by a method which required organic solvents like acetone and methanol. So, chromatographic conditions and parameters of the injection system were optimized to enable the quantification of these solvents.

Keywords: Residual-solvent, Gas chromatography, Nanoparticle, Ophthalmic, Validation.