高效液相色谱法测定可麻滴鼻剂中盐酸麻黄碱和醋酸可的松含量  

Content determination of ephedrine hydrochloride and cortisone acetate in Kema nasal drops by HPLC

作　　者：黄竞[1] 刘洋[1] 张妍[1] 翟所迪[1] 

机构地区：[1]北京大学第三医院药剂科,北京100191

出　　处：《中南药学》2015年第2期186-189,共4页Central South Pharmacy

摘　　要：目的建立可麻滴鼻剂主要成分盐酸麻黄碱和醋酸可的松的含量测定方法。方法采用高效液相色谱法,以Agilent Eclipse XDB-C18（4.6 mm×150 mm,5μm）为分析柱,以磷酸盐缓冲液（取磷酸二氢钾6.8 g,三乙胺5 m L,磷酸4 m L,加水至1 000 m L,用氢氧化钠试液调节p H值至3.0±0.1）-乙腈（90：10）和甲醇-水（65：35）做为流动相,分别对盐酸麻黄碱和醋酸可的松进行含量测定,检测波长分别为210 nm和240nm,流速：1 m L·min^-1。结果盐酸麻黄碱和醋酸可的松与其他组分分离良好。盐酸麻黄碱在10.0-100.0μg·m L^-1内与峰面积线性关系良好（r=0.999 8,n=5）,醋酸可的松在5.0-50.0μg·m L^-1内与峰面积线性关系良好（r=0.999 9,n=6）,盐酸麻黄碱和醋酸可的松的平均加样回收率在99.7%-100.4%（n=3）和100.3%-100.9%（n=3）。结论本测定方法准确、简便,适用于可麻滴鼻剂的质量控制。Objective To improve the quality standard of Kema nasal drops, and establish a method to determine ephedrine hydrochloride and cortisone acetate. Methods HPLC method was adopted. The determination was performed on Agilent Eclipse XDB-C18（4.6 mm×150 mm, 5 μm） column with mobile phase： phosphate buffer（potassium dihydrogen phosphate 6.8 g, triethylamine 5 m L, phosphoric acid 4 m L, adding water to 1 000 m L, p H adjusted to 3.0±0.1 with sodium hydroxide solution）-acetonitrile =（90 ：10）, and methanol-water =（65 ：35） for ephedrine hydrochloride and cortisone acetate, respectively. The detection wavelength was 210 nm and 240 nm, with both flow rates were 1.0 m L·min^- 1. Results Ephedrine hydrochloride and cortisone acetate could be separated from impurities. Ephedrine hydrochloride showed good linearity at 10.0 to 100.0 μg·m L^- 1（r = 0.999 8, n = 5）, while cortisone acetate showed good linearity at 5.0 to 50.0 μg·m L^- 1（r = 0.999 9, n = 6）. The average recovery was 99.7%- 100.4%（n = 3） for ephedrine hydrochloride and 100.3%- 100.9%（n = 3） for cortisone acetate. Conclusion The method is simple and accurate for the content determination of Kema nasal drops.

关 键 词：盐酸麻黄碱 醋酸可的松 质量标准 医院制剂 可麻滴鼻剂 

分 类 号：R917[医药卫生—药物分析学]