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目的:建立HPLC测定硫酸左旋沙丁胺醇缓释微丸胶囊含量及其有关物质。方法:色谱柱:Chirex(S)-ICA and(R)-NEA(250mm×4.6mm,5μm),流动相:正己烷-二氯甲烷-甲醇-三氟乙酸(240:240:20:1),检测波长:278nm,流速:1ml·min~(-1),柱温:30℃,进样量:20μl。结果:硫酸左旋沙丁胺醇检测浓度的线性范围为1.00～6.03μg(r=0.9995);平均回收率为99.94%(RSD=0.1%)。结论:本方法简便、准确、专属性强,可用于该制剂的质量控制。
OBJECTIVE: To establish an HPLC method for the determination of levobuterol sulfate sustained-release pellets and its related substances. METHODS: Chirex (S) -ICA and (R) -NEA (250 mm × 4.6 mm, 5 μm) were used as the mobile phase. The mobile phase consisted of hexane: dichloromethane: methanol: trifluoroacetic acid , Detection wavelength: 278nm, flow rate: 1ml · min ~ (-1), column temperature: 30 ℃, injection volume: 20μl. Results: The linear range of L-salbutamol sulfate was 1.00-6.0μg (r = 0.9995). The average recovery was 99.94% (RSD = 0.1%). Conclusion: The method is simple, accurate and specific and can be used for the quality control of the preparation.