高效液相色谱法测定复方地塞米松庆大霉素滴鼻液中两组分含量  

Determination of Two Components in Compound Dexamethasone and Gentamycin Nasal Drops by HPLC

作　　者：黄夕野 赵建颖 

机构地区：[1]河南省洛阳市药品检验所,河南洛阳471003

出　　处：《中国药业》2007年第2期35-36,共2页China Pharmaceuticals

摘　　要：目的探讨用高效液相色谱法(HPLC法)同时测定复方地塞米松庆大霉素滴鼻液中盐酸麻黄素和地塞米松磷酸钠的含量。方法采用美国Waters高效液相色谱仪,流动相为甲醇-0．1mol/L醋酸铵溶液(50∶50,用磷酸调pH值至4．O),流速为1．0mL/min．检测波长为256nm。结果盐酸麻黄碱和地塞米松磷酸钠在此条件下可实现基线分离,两组分质量浓度线性范围分别为50～500μg/mL(r=0．9995)和3．5～35μg/mL(r=0．9994),平均回收率分别为99．5％(RSD=0．8％)和99．4％(RSD=1．3％)。结论HPLC法简便快速,准确可靠,可作为复方地塞米松庆大霉素滴鼻液的质量控制方法。Objective To establish a method for determining the contents of ephedrine hydrochloride and dexamethasone sodium phosphate in compound dexamethasone and gentamycin nasal drops by HPLC. Methods US Waters high performance liquid chromatograph instrument was utilized and methanol - 0. 1 mol/L ammonium acetate solution （50 ： 50, adjusted pH to 4. 0 with phosphoric acid） was used as the mobile phase with flow velocity 1.0 mL/min and the detective wavelength 256 nm. Results Under this condition, the good separation of the baselines between ephedrine hydrochloride and dexamethasone sodium phosphate could be realized and the linear ranges of ephedrine hydrochloride and dexamethasone sodium phosphate were 50 - 500 μg/mL（ r = 0. 999 5） and 3. 5 - 35μg/mL （ r = 0. 999 4） respectively. The recovery rate was 99.4% （ RSD = 1.3% ） and 99. 5% （ RSD = 0. 9% ） respectively. Conclusion This method is simple, accurate, reliable and suitable for the quality control of compound dexamethasone and gentamycin nasal drops.

关 键 词：高效液相色谱法 盐酸麻黄碱 地塞米松磷酸钠 含量测定 

分 类 号：R927.2[医药卫生—药学] R977.11