Comparison of ultraviolet and liquid chromatographic methods for dissolution testing of sodium phenytoin capsules. 1986

V P Shah, and K E Ogger

An in vitro dissolution procedure for phenytoin (5,5-diphenylhydantoin) products, which utilizes a UV method of analysis, is compared with an HPLC method. The UV method is subject to interference due to inactive materials and decomposition products. One of the inactive materials was identified as the synthetic precursor, benzophenone. The decomposed and degraded capsule contained brown material probably due to alkaline hydrolysis of lactose in the capsule. Both benzophenone and the brown material had significant UV absorption in the phenytoin region. Consequently, a simple, specific, and sensitive HPLC method for dissolution testing of phenytoin has been developed. Comparison of the results of the UV and HPLC methods indicates that the UV method may result in up to 51% higher dissolution values, depending on the presence of inactive ingredients and the purity of the product.

UI MeSH Term Description Entries
D010672 Phenytoin An anticonvulsant that is used to treat a wide variety of seizures. It is also an anti-arrhythmic and a muscle relaxant. The mechanism of therapeutic action is not clear, although several cellular actions have been described including effects on ion channels, active transport, and general membrane stabilization. The mechanism of its muscle relaxant effect appears to involve a reduction in the sensitivity of muscle spindles to stretch. Phenytoin has been proposed for several other therapeutic uses, but its use has been limited by its many adverse effects and interactions with other drugs. Diphenylhydantoin,Fenitoin,Phenhydan,5,5-Diphenylhydantoin,5,5-diphenylimidazolidine-2,4-dione,Antisacer,Difenin,Dihydan,Dilantin,Epamin,Epanutin,Hydantol,Phenytoin Sodium,Sodium Diphenylhydantoinate,Diphenylhydantoinate, Sodium
D002214 Capsules Hard or soft soluble containers used for the oral administration of medicine. Capsule,Microcapsule,Microcapsules
D002851 Chromatography, High Pressure Liquid Liquid chromatographic techniques which feature high inlet pressures, high sensitivity, and high speed. Chromatography, High Performance Liquid,Chromatography, High Speed Liquid,Chromatography, Liquid, High Pressure,HPLC,High Performance Liquid Chromatography,High-Performance Liquid Chromatography,UPLC,Ultra Performance Liquid Chromatography,Chromatography, High-Performance Liquid,High-Performance Liquid Chromatographies,Liquid Chromatography, High-Performance
D001577 Benzophenones Derivatives of benzophenone (with the structural formula phenyl-(C
D012995 Solubility The ability of a substance to be dissolved, i.e. to form a solution with another substance. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed) Solubilities
D013056 Spectrophotometry, Ultraviolet Determination of the spectra of ultraviolet absorption by specific molecules in gases or liquids, for example Cl2, SO2, NO2, CS2, ozone, mercury vapor, and various unsaturated compounds. (McGraw-Hill Dictionary of Scientific and Technical Terms, 4th ed) Ultraviolet Spectrophotometry

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