Assessment of trace aluminium content in parenteral solutions by combined cloud point preconcentration—flow injection inductively coupled plasma optical emission spectrometry

• Published in: Journal of pharmaceutical and biomedical analysis Vol. 30; no. 5; pp. 1451 - 1458
• Main Authors: Sombra, Lorena L, Luconi, Marta O, Fernández, Liliana P, Olsina, Roberto A, Silva, Marı́a F, Martı́nez, Luis D
• Format: Journal Article
• Language: English
• Published: Amsterdam Elsevier B.V 2003; Elsevier Science
• Subjects: Aluminium; Aluminum - analysis; Biological and medical sciences; Cloud point extraction; Flow Injection Analysis - methods; General pharmacology; Inductively coupled plasma atomic emission spectrometry; Medical sciences; Parenteral Nutrition; Parenteral solutions; Pharmaceutical Solutions - analysis; Pharmaceutical technology. Pharmaceutical industry; Pharmacology. Drug treatments; Spectrometry, X-Ray Emission - methods; Cloud point extraction; Parenteral solutions; Aluminium; Inductively coupled plasma atomic emission spectrometry; Trace analysis; Biological fluid; Impurity; Inductive coupling plasma spectrometry; Parenteral administration; Feeding; Blood plasma; Cloud point; Emission spectrometry; Analysis method; Parenteral form; Dosage form; Light metal; Extraction; Quantitative analysis; Chemical contamination; Flow injection
• ISSN: 0731-7085; 1873-264X
• DOI: 10.1016/S0731-7085(02)00483-1

A micelle-mediated phase separation without added chelating agents to preconcentrate trace levels of aluminium in parenteral solutions as a prior step to its determination by flow injection inductively coupled plasma optical emission spectrometry has been developed. The enrichment step is based on the cloud point extraction of aluminium with the non-ionic surfactant polyethyleneglycolmono- p-nonylphenylether (PONPE 7.5). The chemical variables affecting the sensitivity of the extractive-spectrometric procedure were studied in detail. After optimization, a preconcentration factor of 200 and a %E higher than 99.9 were achieved. The detection limit (DL) value of aluminium for the preconcentration of 50 ml of parenteral solution was 0.25 μg l −1. The calibration graph using the preconcentration system for aluminium was linear with a correlation coefficient of 0.9997 at levels near the DLs up to at least 200 μg l −1. The developed hyphenated assay, which thoroughly satisfies the typical requirements for pharmaceutical control processes, is appropriate to monitor the aluminium concentration in parenteral nutrition.