摘要
建立了HPLC法测定罗库溴铵及其注射液中的有关物质。采用氨基键合硅胶为填充剂,以0.04mol/L四甲基氢氧化铵溶液(用磷酸调至pH7.4)-乙腈(10︰90)为流动相,检测波长207nm。在此条件下,罗库溴铵与杂质Ⅰ～Ⅴ达基线分离。3批罗库溴铵原药中杂质Ⅲ的含量均为0.1%,3批罗库溴铵注射液中则均为0.2%;其它杂质均未检出。
An HPLC method was established for the determination of related substances in rocuronium bromide and its injection. An NH2 column was used with the mobile phase of 0.04 mol/L tetramethyl ammonium hydroxide （adjusted to pH 7.4 with phosphoric acid）-acetonitrile （10 ： 90） at detection wavelength of 207 nm. Roeuronium bromide and its related substances including impurities I - V could be well separated. The content of impurity III in three batches of rocuronium bromide was 0.1%, that in three batches of rocuronium bromide injection was 0.2 %, and the other impurities were not detected.
出处
《中国医药工业杂志》
CAS
CSCD
北大核心
2010年第6期441-443,共3页
Chinese Journal of Pharmaceuticals
