TLC Chromatographic-Densitometric Assay of Ibuprofen and Its Impurities

• Published in: Journal of chromatographic science Vol. 48; no. 10; pp. 825 - 829
• Main Authors: Starek, Małgorzata, Krzek, Jan
• Format: Journal Article
• Language: English
• Published: Niles, IL Oxford University Press 01.11.2010; Preston Publications
• Subjects: Analysis; Biological and medical sciences; Chromatography, Thin Layer - methods; Densitometry - methods; Drug Contamination; Drug Stability; General pharmacology; Hydrogen-Ion Concentration; Ibuprofen - chemistry; Medical sciences; Pharmacology. Drug treatments; Validation; Prostaglandin-endoperoxide synthase; Chemical analysis; Impurity; Enzyme; Chemical stability; Enzyme inhibitor; Purity control; Chemical degradation; Acidic solution; Non steroidal antiinflammatory agent; Thin layer chromatography; Ultraviolet detector; Quality control; Ibuprofen; Simultaneous measurement; Arylpropionic acid derivatives; Oxidoreductases; Kinetics; Densitometry; Thermodynamic properties; Degradation product; Quantitative analysis
• ISSN: 0021-9665; 1945-239X
• DOI: 10.1093/chromsci/48.10.825

A simple and sensitive thin-layer chromatographic (TLC)-densitometric method for the quantitative estimation of S(+)-2-[4-isobutylphenyl]propionic acid (ibuprofen) and its impurities in pharmaceutical preparations has been developed. The chromatographic separation was carried out on silica gel 60 F254 TLC plates using toluene-ethyl acetate-glacial acetic acid (17:13: 1, v/v/v) as the mobile phase. Detection was carried out densitometrically with a UV detector. The developed method has detection and quantitation limits ranging from 0.13 µg per spot to 0.72 µg per spot. For individual constituents the recovery ranged from 96.8% to 99.0%. In addition, the stability of ibuprofen solutions was investigated, including the effect of pH, temperature, and incubation time. The method is rapid, simple, and suitable for routine quality-control analysis of pharmaceuticals containing ibuprofen.