Packed column supercritical fluid chromatography of sodium stearyl fumarate aqueous suspension.

J Pharm Biomed Anal

Analytical Development, AstraZeneca R&D Mölndal, S-431 83 Mölndal, Sweden.

Published: March 2006

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.

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http://dx.doi.org/10.1016/j.jpba.2005.07.049DOI Listing

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