生物等效性和生物利用度杂志

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Determination of Rocuronium in Human Plasma by High Performance Liquid Chromatography-Tandem Mass Spectrometry and its Pharmacokinetics in Patients

Yuan Guiyan, Zhang Rui, Wang Benjie, Wei Chunmin, Liu Xiaoyan, Zhao Wenjing and Guo Ruichen

A sensitive and selective high performance liquid chromatography-tandem mass spectrometric (HPLC-MS/MS) method was developed and validated for the determination of rocuronium in human plasma. The plasma samples were separated on an Agilent SB-C18 column (150×2.1 mm, 3.5 μm) with a mobile phase consisted of 20 mM ammonium acetate/methanol/ acetonitrile (20/40/40, v/v/v) at a flow rate of 0.7 mL·min-1. Electrospray ionization (ESI) source was applied and operated in the positive ion mode. Multiple Reaction Monitoring (MRM) modes with the transitions of m/z 529.3→487.3 (rocuronium) and 321.0→275.0 (IS) was used. A good linearity was obtained in the concentration range of 5~3000 μg·L-1 (r=0.9976, n=5). The inter- and intra-day precision (RSD) were less than 8.1%. The extraction recoveries were 92.0~92.6%. Rocuronium in plasma was stable when frozen at -20ºC for 24 hours and seven days, and also stable after two freeze-thawing cycles. The method is simple, quick, sensitive, reproducible and can be used for the pharmacokinetic and bioequivalence study of rocuronium.