HPLC Method for the Determination of EDTA in an Ophthalmic Cleanser

Autor: Giang Tran, R. Brent Miller, C. Chen
Rok vydání: 1996
Předmět:
Zdroj: Journal of Liquid Chromatography & Related Technologies. 19:1499-1508
ISSN: 1520-572X
1082-6076
DOI: 10.1080/10826079608007198
Popis: A reversed-phase high-performance liquid chromatographic (HPLC) procedure using ultra-violet (UV) detection for the analysis of edetate disodium (EDTA) via complexation with iron, in an ophthalmic cleanser, is reported. The method is selective, accurate, and reproducible. The peak area versus EDTA concentration is linear over the range of 50–150% of its label claim of 0.30 mg/mL, with a detection limit of 200 ng/mL. The mean absolute recovery of EDTA, using the described method, is 102.7 ± 0.4% (mean ± SD, n = 10). A stress study with heat, acid, base and UV radiation indicates that the method is stability-indicating with no interference from excipients or degradation products.
Databáze: OpenAIRE