Esterification of pseudoephedrine hydrochloride by citric acid in a solid dose pharmaceutical preparation.

Alok Goel, Zhicheng Zhao,Dan Sørensen, Jay Zhou,Fa Zhang

Journal of Pharmaceutical and Biomedical Analysis(2016)

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摘要
•An unknown degradation product was identified as pseudoephedrine citric acid ester (PSE-CA).•Solid state reaction of PSE with citric acid generated three isomers of PSE-CA.•In aqueous solution, reaction of PSE with citric acid afforded amidation.•Mechanism investigation confirmed formation of PSE-CA in solid dosage form.
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关键词
Pseudoephedrine hydrochloride,Citric acid,Esterification,HPLC–MS,NMR
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