HPLC法测定罗库溴铵注射液的含量及有关物质

目的:建立以高效液相色谱法(HPLC)测定罗库溴铵注射液的含量及有关物质的方法。方法:色谱柱为AgelaNH2柱(250mm×4.6mm,5μm),流动相为0.04mo·lL-1的四甲基氢氧化铵溶液(用磷酸调至pH=7.4)-乙腈(10∶90),流速为1.0mL·min-1,柱温为35℃,检测波长为207nm,进样量为10μL。结果:以罗库溴铵浓度(C)对峰面积(A)进行回归分析,得回归方程为A=1949.88C+18.96,r=0.9999;在检测浓度为0.2001～2.012mg·mL-1范围内呈良好线性关系;平均回收率为99.8%～100.0%,RSD=0.1%(n=9);精密度试验RSD=0.2%。结论:采用HPLC法测定罗库溴铵注射液的含量及有关物质,方法灵敏度高,专属性强,结果准确可靠。

Determination of the Content and Related Substances of Rocuronium Bromide Injection by HPLC

OBJECTIVE： To establish the HPLC method for the determination of content and related substances of Rocuronium bromide injection. METHODS： Agela NH2（250 mm×4.6 mm,5 μm） column was used as the stationary phase. The mobile phase consisted of 0.04 mol·L^-1 tetramethyl ammonium hydroxide（pH adjusted to 7.4 with phosphoric acid） and acetonitrile（10 ∶ 90）. The flow rate was 1.0 mL·min^-1. The column temperature was set at 35 ℃ and detection wavelength was 207 nm. Injection volume was 10 μL. RESULTS： The linear range of rocuronium bromide was 0.200 1～2.012 mg·mL^-1（A=1 949.88C＋18.96, r=0.999 9）. The average recovery was 99.8%～100.0%（RSD=0.1%, n=9） The RSD of precision test was 0.2%. CONCLUSION： This method is exclusive,sensitive and reliable for content determination of Rocuronium bromide injection.