摘要
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,5μm),流动相为磷酸盐缓冲液(取磷酸二氢钾6.8 g,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=0.999 9,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。
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,adjust-ing 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 5.08-81.38 μg/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.
出处
《中国药业》
CAS
2013年第9期17-18,共2页
China Pharmaceuticals
基金
2011年深圳市龙岗区医疗卫生类科技计划项目
项目编号:YS2011040
