| Literature DB >> 9696572 |
A S Kord1, I Tumanova, W L Matier.
Abstract
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.Entities:
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Year: 1995 PMID： 9696572 DOI： 10.1016/0731-7085(95)01254-i
Source DB: PubMed Journal: J Pharm Biomed Anal ISSN： 0731-7085 Impact factor: 3.935