Please use this identifier to cite or link to this item: http://hdl.handle.net/10637/736

Validation of an HPLC method for the determination of ambroxol hydrochloride and benzoic acid in a syrup as pharmaceutical form: stress test for stability evaluation.

Title: Validation of an HPLC method for the determination of ambroxol hydrochloride and benzoic acid in a syrup as pharmaceutical form: stress test for stability evaluation.
Authors : Heinänen, Maarit
Barbas Arribas, Coral.
Keywords: AmbroxolBenzoic acidHPLCSyrupPharmaceutical
Abstract: A method is described for ambroxol, trans-4-(2-amino-3,5-dibromobenzylamino) cyclohexanol hydrochloride, and benzoic acid separation by HPLC with UV detection at 247 nm in a syrup as pharmaceutical presentation. Optimal conditions were: Column Symmetry Shield RPC8, 5 mm 250×4.6 mm, and methanol/(H3PO4 8.5 mM/triethylamine pH=2.8) 40:60 v/v. Validation was performed using standards and the pharmaceutical preparation which contains the compounds described above. Results from both standards and samples show suitable validation parameters. The pharmaceutical grade substances were tested by factors that could influence the chemical stability. These reaction mixtures were analysed to evaluate the capability of the method to separate degradation products. Degradation products did not interfere with the determination of the substances tested by the assay.
Description: En: Journal of pharmaceutical and biomedical analysis. ISSN. 0731-7085. v. 24, 5-6 (2007), p. 999-1004
URI: http://hdl.handle.net/10637/736
Rights : http://creativecommons.org/licenses/by-nc-nd/4.0/deed.es
Issue Date: 19-Sep-2001
Center : Universidad San Pablo-CEU
Appears in Collections:Facultad de Farmacia





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