HPLC测定硫酸沙丁胺醇雾化吸入溶液有关物质方法的研究  

Determination of Related Substances in Salbutamol Sulfate Nebules Inhalation Solution by HPLC

作　　者：张冬梅[1] 牛冲[1] 冷佳蔚[1] 

机构地区：[1]山东省食品药品检验所,山东济南250101

出　　处：《食品与药品》2012年第11期416-418,共3页Food and Drug

摘　　要：目的研究建立测定硫酸沙丁胺醇雾化吸入溶液中有关物质的HPLC方法.方法采用Agilent ZORBAX SB-C8柱(250mm×4.6 mm,5μm);柱温:35℃;流动相:庚烷磺酸钠溶液–乙腈(78∶22);流速:1.5 mL/min;检测波长:220 nm。结果硫酸沙丁胺醇主峰与各分解产物峰分离良好,硫酸沙丁胺醇的检出限为1.0 ng。结论此方法准确、简便、快速,适用于硫酸沙丁胺醇雾化吸入溶液的质量控制。Objective To establish a HPLC method for the determination of related substances in Salbutamol Sulfate Nebules Inhalation Solution. Methods The HPLC was performed on an Agilent ZORBAX SB-C8 column（250 mm × 4.6 mm, 5 μm） with the mixture of 22 volumes of acetonitrile and 78 volumes of the solution containing 2.87 g/L of sodium heptanesulfonate and 2.5 g/L of potassium dihydrogen phosphate R previously adjusted to pH 3.65 with dilute phosphoric acid solution as the mobile phase. The detection wavelength was 220 nm. The flow rate was 1.5mL.min. The temperature of the column was 35℃. Results An excellent separation was achieved for salbutamol sulfate and its related substances. The LOD of salbutamol sulfate was 1.0ng. Conclusion This method is accurate, simple, quick and effective for testing related substances in Salbutarnol Sulfate Nebules Inhalation Solution. It is suitable for the quality control of Salbutamol Sulfate Nebules Inhalation Solution.

关 键 词：硫酸沙丁胺醇 有关物质 高效液相色谱法 

分 类 号：R974.3[医药卫生—药品]