Simultaneous determination of rocuronium and its eight impurities in pharmaceutical preparation using high-performance liquid chromatography with amperometric detection.
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 microm (250 mm x 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.
Błazewicz
Agata
A
Department of Pharmaceutical Chemistry, National Medicines Institute, Warsaw, Poland. ablazewicz@il.waw.pl <ablazewicz@il.waw.pl>
Fijałek
Zbigniew
Z
Warowna-Grześkiewicz
Małgorzata
M
Boruta
Magdalena
M
D000732:Androstanols / Q000032:analysis*; D002851:Chromatography, High Pressure Liquid / Q000379:methods*; D004563:Electrochemistry / Q000379:methods*; D009467:Neuromuscular Depolarizing Agents / Q000032:analysis*; D004364:Pharmaceutical Preparations / Q000737:chemistry*; D000077123:Rocuronium
D000732:Androstanols; D009467:Neuromuscular Depolarizing Agents; D004364:Pharmaceutical Preparations; D000077123:Rocuronium