Presentation Description:Mass spectrometry is turning a new page in pharmaceutical analysis with its significant analytical capability and wide-ranging applications. The use of mass spectrometry to evaluate pharmaceuticals in complex biological matrices has facilitated the implementation sensitive and specific methods for the analysis of local and systematic drug exposure. Sustained-release dexamethasone intravitreal implants offer promising solutions to the treatment of inflammatory conditions in various ocular diseases by overcoming the limitations of topical and systemic administrations and the burden of repeated direct injections of dexamethasone. However, designing bioequivalence studies for a generic dexamethasone intravitreal implant is very challenging in view of the route of administration and the prolonged application duration. A platform of highly sensitive and specific UPLC-MS/MS methods was developed and validated for the simultaneous determination of dexamethasone and its major metabolite 6β-hydroxydexamethasone in rabbit biological matrices (plasma, aqueous humor, vitreous humor, and retina) to support bioequivalence studies of dexamethasone intravitreal implant drugs. Highlights include both analytical sensitively and for the first time that a mass spectrometry method was reported for the simultaneous determination of dexamethasone and 6β-hydroxydexamethasone in ocular matrices.
Understand the regulatory scale of bioanalytical method validation in different biological matrices
Describe the development of a mass spectrometry platform to evaluate dexamethasone in various biological matrices
Summarize the applications of mass spectrometry in pharmaceutical analysis