CAJ | 학술논문

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(250 mm×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.
목적연구건립측정류산사정알순무화흡입용액중유관물질적HPLC방법.방법채용Agilent ZORBAX SB-C8주(250 mm×4.6 mm,5μm);주온:35℃;류동상:경완광산납용액–을정(78∶22);류속:1.5 mL/min;검측파장:220 nm.결과류산사정알순주봉여각분해산물봉분리량호,류산사정알순적검출한위1.0 ng.결론차방법준학、간편、쾌속,괄용우류산사정알순무화흡입용액적질량공제.
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 Salbutamol Sulfate Nebules Inhalation Solution.It is suitable for the quality control of Salbutamol Sulfate Nebules Inhalation Solution.