Simultaneous determination of rocuronium and its eight impurities in pharmaceutical preparation using high-performance liquid chromatography with amperometric detection

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• 作者：Agata Bł ; aż ; ewicz ; Zbigniew Fijał ; ek ; Mał ; gorzata Warowna-Grze&#x15b ; kiewicz ; Magdalena Boruta
• 关键词：Rocuronium ; Impurities ; Pharmaceutical analysis ; HPLC-ED ; Electrochemical detection ; Amperometric detection
• 刊名：Journal of Chromatography A
• 出版年：2007
• 期刊代码：47_00219673
• 类别：ch
• 出版时间：11 May 2007
• 卷：1149
• 期：1
• 页码：66-72
• 文件大小：176 K

摘要

A sensitive and selective HPLC method with amperometric detection (HPLC-ED) for the determination of rocuronium bromide and its eight impurities has been developed. The analysis was performed on Hypersil 100 Silica column 5 μm (250 mm × 4.6 mm; Thermo Electron). The mobile phase consisting of 4.53 g l⁻¹ solution of tetramethylammonium hydroxide adjusted to pH 7.4 with 85%phosphoric acid:acetonitrile (1:9), was found the best for the separation and determination of the studied compounds. The chromatograms were recorded over 10 min using the amperometric detection at a potential +0.9 V of the glassy carbon electrode versus the reference electrode Ag/AgCl. The limit of quantitation was 45 ng ml⁻¹ for rocuronium and from 25 to 750 ng ml⁻¹ for the examined impurities. The proposed HPLC-ED method was successfully applied to the analysis of rocuronium and its impurities in Esmeron solution for injection.