Abstract
Quality-by-design based development of a stability indicating method for antiviral ophthalmic ointment
Highlights
Some ocular pathologies such as herpes simplex, virus retinitis and acute retinal necrosis are usually treated by administering antiviral drug product
Since our purpose is to develop robust and reproducible method with reasonable percent of organic modifier, methanol was chosen as organic solvent in mobile phase for stages of method optimization
Inertsil ODS-3V 250-4.6 mm (5μm) column provides broad range of combinations of screening conditions at which the specified criteria meet the set goals, it is selected for method optimization step
Summary
Some ocular pathologies such as herpes simplex, virus retinitis and acute retinal necrosis are usually treated by administering antiviral drug product. The base is designed to have melting point close to human body temperature and can be used as anhydrous medium for the delivery of moisture-sensitive drugs. Several methods have been reported for the determination of this active component in pharmaceutical formulations, based on different analytical techniques. HPLC method for the assay of active compounds is superior to other conventional methods in speed, precision, specificity and ease of performance. The aim of our work was to develop rapid HPLC assay method for determination of antiviral active compound by implementation of QbD principles. Quality by design approach in method development help to better understand chromatographic variables in less time compared to traditional, one factor at a time method development (Gayakwad et al, 2015; Karmarkar et al, 2011)
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