RP-HP LC测定注射液中甲硫酸新斯的明含量

摘要

Reverse high performance liquid chromatography ( RP-HPLC) was set up to determine the neostigmine methylsulfate in injection. The C18 colum(4.6×150 mm,5 μm) was used with the mobile phase consisted of 0.1% phosphoric acid solution(pH was adjusted to 3.0 by triethylamine)-methanol(90 ∶ 10)and the detection wavelength of 260 nm. The results showed that neostigmine methylsulfate had the good linear relationship at the range of 2~500 μg·mL-1(R2=0.9999) and the mean recovery rate was 100.2%~100.8%(RSD=0.7%~1.2%).The method was simple,accurate and robust for the quality control of neostigmine methylsulfate injection.%建立了反向高效液相色谱法（ RP-HP LC ）测定注射液中甲硫酸新斯的明的含量。采用C18柱（4．6×150 mm，5μm），以0．1％磷酸水溶液（用三乙胺调pH至3．0）-甲醇（90∶10）为流动相，260 nm为检测波长。试验结果表明，甲硫酸新斯的明在2～500μg/mL 范围内线性关系良好， R2＝0．9999，平均回收率范围为100．2％～100．8％，RSD范围为0．7％～1．2％。该方法简便、精确、重现性好，可用于甲硫酸新斯的明注射液的质量控制。