Determination of Epoxy Compound in Rocuronium Bromide Condensation Compound by LC-MS

OBJECTIVE To establish a LC-MS method for the determination of epoxy compound in rocuronium bromide condensation compound. METHODS The analysis was carried out on an Agilent Eclipes XDB-C₁₈ column(150 mm×2.1 mm, 3 μm), using a gradient elution of methanol and 0.1% formic acid as the mobile phase at a flow rate of 0.25 mL·min^-1 at 30 ℃, ion source was APCI, acquisition mode was SIM positive ionization, and selected ion was m/z 347.2 (M+H⁺). RESULTS The LOQ was 0.000 3%, the LOD was 0.000 09%; there was no influence on sample testing when small changes were made in the chromatographic conditions; the average recovery was 98.9% with RSD of 8.41%(n=3). CONCLUSION The method was sensitive, accurate, and suitable for the limit determination of epoxy compound in rocuronium bromide condensation compound.