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Packed column supercritical fluid chromatography of sodium stearyl fumarate aqueous suspension
Authors:Gyllenhaal Olle
Affiliation:1. Department of Organic Chemistry and Technology, Budapest University of Technology and Economics, H-1111 Budapest, Műegyetem rakpart 3, Hungary;2. Department of Chemical Engineering, University of Kentucky, Lexington, KY, USA;1. Laboratory of Pharmaceutical Technology, Ghent University, Belgium;2. Laboratory of Pharmaceutical Process Analytical Technology, Ghent University, Belgium;3. Global Technical Services, Janssen Supply Chain, Janssen Pharmaceutica, Belgium;4. Department of Pharmaceutical Development, Johnson&Johnson Pharmaceutical Research and Development, Janssen Pharmaceutica, Belgium;1. State Key Laboratory for Diagnosis and Treatment of Infectious Disease, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, Zhejiang University, Hangzhou 31003, PR China;2. College of Pharmaceutical Sciences, Zhejiang University, Hangzhou 310058, PR China;3. Wenzhou Medical University,Wenzhou 325035, PR China;1. Institute of Experimental Physics, University of Gdansk, Wita Stwosza 57, 80-952 Gdansk, Poland;2. Sector of Spectroscopy, Vlokh Institute of Physical Optics, Dragomanov St. 23, 79-005 Lviv, Ukraine;3. Division of Spectroscopy of Functional Materials, Institute of Physics, University of Zielona Gora, Szafrana St. 4a, 65-516 Zielona Gora, Poland;1. College of Physics and Electronic Engineering, Henan Normal University, Xinxiang, Henan, 453007, People''s Republic of China;2. Xinxiang Battery Research Institute, Xinxiang, Henan, 453007, People''s Republic of China
Abstract:
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.
Keywords:
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