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目的:建立正相高效液相色谱拆分盐酸普萘洛尔对映异构体的方法。方法:采用自行合成的纤维素衍生物大粒径手性固定相,考察了拆分方法,以正己烷-异丙醇-三乙胺溶液(95∶5∶0.1%)为流动相,流速0.5mL·min-1,检测波长为276nm。结果:盐酸普萘洛尔两对映异构体的保留时间分别为8.67mim、14.36min,分离度良好;日内、日间精密度的RSD均小于3%。加样回收率在95.5%～101.4%之间,RSD为2.4%。结论:结果表明所建立的大粒径纤维素衍生物手性固定相高效液相色谱拆分盐酸普萘洛尔制剂中对映异构体的方法,简便、可靠、高效,可用于盐酸普萘洛尔制剂中对映异构体的测定。
Objective: To establish a method for the resolution of propranolol hydrochloride enantiomer by normal phase high performance liquid chromatography. Methods: The self-synthesized cellulose derivatives with large particle size were used for the resolution. The mobile phase was n-hexane-isopropanol-triethylamine solution (95: 5: 0.1% mL · min-1, the detection wavelength was 276nm. Results: The retention times of propranolol hydrochloride enantiomers were 8.67mim and 14.36min, respectively. The RSDs of intra-day and inter-day precision were less than 3%. The recoveries of samples ranged from 95.5% to 101.4% with a RSD of 2.4%. Conclusion: The established method for the separation of enantiomers from propranolol hydrochloride preparations by high performance liquid chromatography (LC) with large particle size cellulose derivatives as chiral stationary phase is simple, reliable and efficient and can be used for the determination of propranolol hydrochloride Determination of enantiomers in lol formulations.