RP-HPLC测定注射液中甲硫酸新斯的明含量

Determination of Neostigmine Methylsulfate in Injection by RP-HPLC

关键词:  甲硫酸新斯的明  RP-HPLC

Key words:  Neostigmine Methylsulfate  RP-HPLC

摘要:

建立了反向高效液相色谱法(RP-HPLC)测定注射液中甲硫酸新斯的明的含量。采用C18柱(4.6×150 mm,5 μm),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。实验结果表明,甲硫酸新斯的明在10～2000 ng.mL_-1范围内线性关系良好,R₂=0.9999,平均回收率范围为99.2%～100.8％,RSD=0.52%。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。

Abstract:

Reverse high performance liquid chromatography (RP-HPLC) was set up to determinie the Neostigmine Methylsulfate in injection.The C₁₈ colum(4.6×150mm,5μm) 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 260nm. The results showed that Neostigmine Methylsulfate had the good linear relationship at the range of 10～2000ng.mL_-1(R₂=0.9999) and the mean recovery rate was 99.2%～100.8％(RSD=0.52%).The method was simple,accurate and robust for the quality control of Neostigmine Methylsulfate injection.