高效液相色谱法测定盐酸麻黄碱注射液中盐酸麻黄碱含量

摘要

Objective To establish a method for the determination of ephedrine hydrochloride in Ephedrine Hydrochloride Injection by HPLC.Methods The Agilent Eclipse XDB-C18 column (150 mm ×4.6 mm,5 μm) was adopted with the mobile phase of phosphate buffer (taking potassium dihydrogen phosphate 6.8 g,triethylamine 5 mL and phosphoric acid 4 mL,adding water to 1 000 mL,adjusting the pH value to 3.0±0.1 with dilute phosphoric acid)-acetonitrile (91∶9).The mobile rate was 1.0 mL/min.The detection wavelength was at 210 nm.The column temperature was 25 ℃.The external standard method was adopted to measure the content.Results The linear range was 5.08-81.38μg/mL(r =0.999 9,n=6).The average recovery rate was 99.57％,RSD =0.35％ (n =9).Conclusion This method is simple,accurate,specific,reproducible and can be used for the determination of ephedrine hydrochloride in Ephedrine Hydrochloride Injection.%目的 建立测定盐酸麻黄碱注射液中盐酸麻黄碱含量的高效液相色谱法.方法 采用Agilent Eclipse XDB-C18柱(150 mm ×4.6 mm,5 μm),流动相为磷酸盐缓冲液(取磷酸二氢钾6.8g,三乙胺5 mL,磷酸4 mL,加水至1 000 mL,用稀磷酸调节pH至3.0±0.1)-乙腈(91∶9),流速为1.0 mL/min,检测波长为210 nm,柱温为25℃,外标法测定含量.结果 盐酸麻黄碱质量浓度在5.08 ～81.38μg/mL范围内与峰面积积分值线性关系良好(r=0.9999,n=6),平均加样回收率为99.57％,RSD =0.35％ (n =9).结论 该法简便、准确,专属性强,重复性好,可用于测定盐酸麻黄碱注射液中盐酸麻黄碱的含量.