高效液相色谱法测定甲磺酸酚妥拉明注射液的含量  

Determination of Phentolamine Mesylate in Phentolamine Mesylate Injection by High Performance Liquid Chromatography

作　　者：刘玉波[1] 车慧[1] 刘艳娥[1] 靳守东[1] 陈善[1] 

机构地区：[1]总后勤部卫生部药品仪器检验所,北京100071

出　　处：《解放军药学学报》2011年第4期341-343,共3页Pharmaceutical Journal of Chinese People's Liberation Army

摘　　要：目的建立高效液相色谱法测定甲磺酸酚妥拉明注射液的含量。方法色谱柱：Capcell pak,C18（250 mm×4.6 mm ID,5μm）;流动相：乙腈-水（含0.01 mol/L庚烷磺酸钠,0.1%三乙胺,用磷酸调节pH=3.0）（36∶64）;检测波长：278 nm;柱温：40℃;流速：1 ml/min。结果甲磺酸酚妥拉明在51.34~513.4μg/ml浓度范围内线性关系良好。平均回收率为99.41%,RSD为0.36%。结论本法可用于甲磺酸酚妥拉明注射液的含量测定,控制质量。Objective To establish an high performance liquid chromatography method for determination of the content of phentolamine mesylate in phentolamine mesylate injection.Methods High performance liquid chromatography analysis was carried out using Capcell pak,C18（250 mm×4.6 mm ID,5 μm）column and acetonitrile-water（containing 0.01mol/L heptane sodium sulfonate and 0.1% triethylamine adjusted to pH 3.0 with phosphoric acid.）（36∶64） as the mobile phase.The detection wavelength was 278 nm;the flow rate was 1.0 ml/min,and the column temperature was 40℃.Results The linear range was 51.34-513.4 μg/ml.The average recovery was 99.41%,and RSD was 0.36%.Conclusion This method can be used for quality control of phentolamine mesylate injection.

关 键 词：甲磺酸酚妥拉明 甲磺酸酚妥拉明注射液 高效液相色谱法 含量测定 

分 类 号：R927.2[医药卫生—药学]