Rifaximin, a semisynthetic, rifamycin-based non-systemic antibiotic is used in the treatment of acute and chronic gastrointestinal disorders. The aim of this study was the elucidation of the molecular structure of the 802 Dalton impurity which was found in Rifaximin industrial batches and reported with an erroneous structure in European Pharmacopoeia 6.5 (2009) [7] monograph as Rifaximin Impurity H. This impurity was isolated from Rifaximin by preparative HPLC and purified by column chromatography. The molecular structure was evidenced by means of 1H and 13C NMR spectroscopy, mass spectrometry and FT-IR.

Structural elucidation of the Rifaximin Ph. Eur. Impurity H / R. Stradi, D. Nava, M. Nebuloni, B. Pastura, E.R.E. Pini. - In: JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS. - ISSN 0731-7085. - 51:4(2010), pp. 856-865.

Structural elucidation of the Rifaximin Ph. Eur. Impurity H

R. Stradi;D. Nava;E.R.E. Pini
2010

Abstract

Rifaximin, a semisynthetic, rifamycin-based non-systemic antibiotic is used in the treatment of acute and chronic gastrointestinal disorders. The aim of this study was the elucidation of the molecular structure of the 802 Dalton impurity which was found in Rifaximin industrial batches and reported with an erroneous structure in European Pharmacopoeia 6.5 (2009) [7] monograph as Rifaximin Impurity H. This impurity was isolated from Rifaximin by preparative HPLC and purified by column chromatography. The molecular structure was evidenced by means of 1H and 13C NMR spectroscopy, mass spectrometry and FT-IR.
802 Dalton impurity; European Pharmacopoeia; HPLC/MS/MS; Rifaximin; Spectroscopic techniques; Structural elucidation
Settore CHIM/06 - Chimica Organica
2010
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/170724
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