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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 an HPLC method for the determination of related substances in salbutamol sulphate inhalation solution.METHODS Agilent ZORBAX SB-C8 column (250 mm × 4.6 mm, 5 μm) was used.Method: Column temperature was 35 ℃ .The mobile phase was heptane sulfonate solution- Acetonitrile (78:22); flow rate: 1.5 mL / min; detection wavelength: 220 nm. Results The main peak of salbutamol sulfate was separated from each decomposition product peak. The detection limit of salbutamol sulfate was 1.0 ng. Conclusion This method is accurate, simple and rapid, suitable for the quality control of salbutamol sulfate inhalation solution.