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目的:建立手性高效液相色谱法测定盐酸左旋沙丁胺醇缓释片的含量及右旋异构体。方法:采用Chirex(S)-ICA和(R)-NEA手性柱,以正己烷-二氯甲烷-甲醇-三氟醋酸(240∶140∶20∶1)为流动相,流速为1.0mL.min-1,检测波长为278nm。结果:盐酸左旋沙丁胺醇与其右旋体分离度良好,在0.06168～0.6168g.L-1范围内与峰面积线性关系良好,(r=0.9991),平均回收率为99.6%;最低检测限为12ng。结论:所建立的方法可用于该制剂的质量控制。
Objective: To establish a chiral HPLC method for the determination of levobuterol hydrochloride sustained-release tablets and dextrorotatory isoforms. Methods: The mobile phase consisted of Chirex (S) -ICA and (R) -NEA chiral column with n-hexane-methylene chloride-methanol-trifluoroacetic acid (240:140: 20: 1) min-1, detection wavelength of 278nm. Results: The separation of L-salbutamol hydrochloride and its dextrose was good, with a good linear relationship with the peak area in the range of 0.06168 ~ 0.6168g.L-1 (r = 0.9991). The average recovery was 99.6%. The minimum detection limit was 12ng. Conclusion: The established method can be used for the quality control of the preparation.