Packed column supercritical fluid chromatography of sodium stearyl fumarate aqueous suspension.
A method for the determination of sodium stearyl fumarate aqueous suspension is described. This straightforward method is based on homogenisation of the sample, dilution of a known aliquot with methanol to a suitable clear solution and mixing with an internal standard; (S)-naproxen. Separation and quantification is performed by packed column supercritical fluid chromatography on a commercial tartaric acid network polymeric column (tertbutylbenzoyl) with UV-detection at 214 nm. The precision of the presented method upon repeated analysis of a 20 mg/ml suspension is 0.5% (n = 8), and the yield is near 100%. Less than 5 min is required for the chromatographic separation with a resolution of about 3 to the internal standard. With some modification of the chromatographic conditions water samples can also be analysed.
Gyllenhaal
Olle
O
Analytical Development, AstraZeneca R&D Mölndal, S-431 83 Mölndal, Sweden. olle.gyllenhaal@astrazeneca.com
D025924:Chromatography, Supercritical Fluid / Q000379:methods*; D005079:Excipients / Q000032:analysis* / Q000737:chemistry; D005650:Fumarates / Q000032:analysis* / Q000737:chemistry; D000432:Methanol; D015203:Reproducibility of Results; D013056:Spectrophotometry, Ultraviolet; D013535:Suspensions; D014867:Water
D005079:Excipients; D005650:Fumarates; D013535:Suspensions; D014867:Water; C519579:sodium stearyl fumarate; D000432:Methanol