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.
Kord
A S
AS
Oculon Corporation, Cambridge, MA 02139, USA.
Tumanova
I
I
Matier
W L
WL
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