A novel HPLC method for determination of EDTA in a cataract inhibiting ophthalmic drug.
A novel HPLC method for determination of EDTA in a cataract inhibiting ophthalmic drug product has been developed. In this method EDTA was converted to Cu(II)EDTA complex, using Cu + 2 containing mobile phase, after injection into the chromatographic system. This allowed complexation of EDTA with Cu + 2 without interference from formulation ingredients. The Cu(II)EDTA complex was separated from drug substance, impurities, degradants and other formulation excipients by a 250 x 4.1 mm anion exchange column and detected at UV wavelength 250 nm. The mobile phase consisted of 2 mM cupric nitrate, 11 mM nitric acid, and 25% (v/v) acetonitrile at pH 3.0. This stability indicating assay has been validated and shown to be specific, linear, precise, accurate and rugged for routine EDTA analysis.
Oculon Corporation, Cambridge, MA 02139, USA.
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Kord
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Tumanova
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D002386:Cataract / Q000188:drug therapy*; D002851:Chromatography, High Pressure Liquid; D003300:Copper / Q000737:chemistry; D004492:Edetic Acid / Q000032:analysis* / Q000737:chemistry; D009883:Ophthalmic Solutions; D013056:Spectrophotometry, Ultraviolet
D009883:Ophthalmic Solutions; D003300:Copper; D004492:Edetic Acid