HPLC测定罗库溴铵注射液的含量

Determination of the Content of Rocuronium Bromide Injection by HPLC

关键词:  罗库溴铵注射液  含量测定  高效液相色谱法

Key words:  rocuronium bromide injection  content assay  HPLC

摘要:

目的 采用高效液相色谱法测定罗库溴铵注射液的含量。方法 采用氨基键合硅胶为填充剂，以0.04 mol·L-1的四甲基氢氧化铵溶液(用磷酸调节pH值至7.4)-乙腈(10︰90)为流动相，柱温为35 ℃，检测波长为210 nm。结果 线性范围为0.200 8～2.006 mg·mL-1；r =0.999 9；样品溶液在 24 h内稳定；平均回收率为99.7％～99.9％，RSD<1.0％(n=9)；重复性RSD为0.4％。结论 采用高效液相色谱法测定罗库溴铵注射液的含量，方法灵敏度高，专属性强，结果准确可靠。

Abstract:

OBJECTIVE To establish the HPLC method for the determination of content of rocuronium bromide injection. METHODS Agela NH2 column was used as the stationary phase. The mobile phase consisted of 0.04 mol·L-1 tetramethyl ammonium hydroxide (adjust pH to 7.4 with phosphoric acid) and acetonitrile (10︰90). The column temperature was 35 ℃.The detection wavelength was 210 nm. RESULTS The method was proved to be linear in the range of 0.200 8-2.006 mg·mL-1 with a regression coefficient of 0.999 9．The average recovery percentage of the method was 99.7％-99.9％ with RSD<1.0% (n=9)．The RSD of average contents of repeatability was 0.4%．CONCLUSION This method is exclusive，sensitive and can be reliable for the quality control of rocuronium bromide injection.