Fast Determination of 4-Hydroxybenzoic Acid in Different Matrices using Monolithic Column Separation

Autor: Daniel Abran, Louis-Philippe Labranche, Alain Carrier, Audrey Tousignant
Rok vydání: 2008
Předmět:
Zdroj: Journal of Liquid Chromatography & Related Technologies. 31:2575-2586
ISSN: 1520-572X
1082-6076
DOI: 10.1080/10826070802352777
Popis: Determination of impurity levels in injectable formulation is an important issue with regulatory agencies. Impurities associated with preservatives systems are questioned and the use of adequate tools and the accumulation of a large body of data are required to ensure the pharmaceutical quality of products. Liquid Chromatography combined with UV detection can be adapted to provide a powerful tool for impurity analyses in injectable solution formulations. Using an Onyx 100 × 4.6 mm monolithic column coupled with high flow rates (> 5 mL/min) and UV detection at 254 nm, parabens synthetic pathway residue and degradation products were quantified in less than 1 minute. The analyses involved simple sample preparation and rapid run-time chromatography. Using these conditions, recoveries of 97.3 to 100.0% at three impurity levels (0.375, 0.750, and 1.125% of the active drug) were obtained for an injectable formulation containing indazole based active drugs. Injectables containing steroid and imidazole ba...
Databáze: OpenAIRE
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