RP-HPLC法测定甲硫酸新斯的明注射液的含量

Content determination of neostigmine methylsulfate injection by RP-HPLC

目的 建立高效液相色谱法测定甲硫酸新斯的明注射液中甲硫酸新斯的明含量的方法。方法 采用C8色谱柱（250mm×4.6mm,5μm）,流动相为0.05mol·L^-1磷酸二氢钾（用磷酸调pH至3）-乙腈（87∶13）,流速1.0mL·min^-1,检测波长260nm。结果 甲硫酸新斯的明在6.12-14.28μg范围内,呈良好的线性关系（r=0.9999）,平均回收率为99.9%（n=9）,RSD为0.26%（n=9）。结论 本法快速、简便、准确,可用于该制剂的质量控制。

OBJECTIVE An RP-HPLC method was developed to determine the content of neostigmine methylsulfate injection. METHODS The content of neostigmine methylsulfate injection was determined on Phenomenex Luria C8 column （250 mm × 4.6 mm, 5um）.The mobile phase used were 0.05 mol·L^-1 potassium dihydrogan phospate-acetonitrile （87： 13） at a flow rate of 1.0 mL· min^- 1 and detected at 260 nm. RESULTS The linear relationship of the peak area and concentration was determined as 6.12 - 14.28ug with a regression coefficient of 0. 9999. The average recovery was 99.9 %, RSD was 0.26 %. CONCLUSION The method is rapid, simple, accurate and can be used for quality control.