A novel HPLC method for determination of EDTA in a cataract inhibiting ophthalmic drug.
J Pharm Biomed Anal
; 13(4-5): 575-80, 1995 Apr.
Article
en En
| MEDLINE
| ID: mdl-9696572
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.
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Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Catarata
/
Ácido Edético
Idioma:
En
Revista:
J Pharm Biomed Anal
Año:
1995
Tipo del documento:
Article
País de afiliación:
Estados Unidos