Investigation of sorbic acid volatile degradation products in pharmaceutical formulations using static headspace gas chromatography.
An analytical method that allows simultaneous analysis of sorbic acid and its degradation products was developed using static headspace gas chromatography (HS-GC). AT-Aquawax-DA, the capillary column used, showed good selectivity and separation towards sorbic acid and its degradation products. Sorbic acid degradation was investigated in both acidic and aqueous media at room and elevated temperatures. In total 12 sorbic acid degradation products were found, 8 of which could be characterized. The method was investigated for its accuracy towards estimation of degradation products. Using the HS-GC method different batches of pharmaceutical preparations such as cold cream, cetomacrogol cream and vaseline were investigated for sorbic acid degradation products which were estimated by applying the standard addition method. Acetaldehyde was found to be the major degradation product. The other identified degradation products were: acetone; 2-methylfuran; crotonaldehyde; alfa-angelicalactone; 2-acetyl, 5-methylfuran; toluene and 2,5-dimethylfuran. Both mass spectrometeric (MS) and flame ionization detection (FID) were used. The qualitative investigation was done on HS-GC-MS and the quantitative work on HS-GC-FID.
Yarramraju
Sitaramaraju
S
Laboratorium voor Farmaceutische Analyse, Faculteit Farmaceutische Wetenschappen, Katholieke Universiteit Leuven, O & N 2, Herestraat 49 (PB 923), B-3000 Leuven, Belgium. Sitaramaraju.Yarramraju@pharm.kuleuven.be
Akurathi
Vamsidhar
V
Wolfs
Kris
K
Van Schepdael
Ann
A
Hoogmartens
Jos
J
Adams
Erwin
E
D002626:Chemistry, Pharmaceutical; D002849:Chromatography, Gas; D004340:Drug Contamination; D005410:Flame Ionization; D008401:Gas Chromatography-Mass Spectrometry; D007202:Indicators and Reagents; D009824:Ointments / Q000032:analysis; D012015:Reference Standards; D015203:Reproducibility of Results; D012996:Solutions; D013011:Sorbic Acid / Q000032:analysis*; D013696:Temperature
D007202:Indicators and Reagents; D009824:Ointments; D012996:Solutions; D013011:Sorbic Acid