HPLC法同时测定扑麻滴鼻液中2成分的含量  

Simultaneous Determination of Two Components in Chlorphenamine Maleate and Ephedrine Nasal Drops by HPLC

作　　者：金丽[1] 周建丽[1] 张晓丹[1] 伍小勇[1] 卜莹[1] 古卓良[1] 

机构地区：[1]南京军区联勤部药品仪器检验所,南京210002

出　　处：《中国药师》2015年第4期687-689,共3页China Pharmacist

基　　金：军队医疗机构制剂标准提高科研专项重点课题(编号:13ZJZ07)

摘　　要：目的：建立同时测定扑麻滴鼻液中盐酸麻黄碱和马来酸氯苯那敏含量的HPLC方法。方法：采用：PurospherSTAR RP18色谱柱（150 mm×4.6 mm,5μm）,以磷酸盐缓冲液（p H 3.0±0.1）-乙腈（82∶18）为流动相,流速为1.0 ml·min^-1,在210nm波长处同时检测盐酸麻黄碱和马来酸氯苯那敏,柱温35℃,进样量20μl。结果：盐酸麻黄碱和马来酸氯苯那敏分别在19.81-118.85μg·mL^-1和6.21-37.25μg·mL^-1浓度范围内线性关系良好,r分别为0.999 6和0.999 8。平均回收率分别为100.39%（RSD=0.69%,n=9）和100.11%（RSD=0.60%,n=9）。结论：该方法快速简便、重复性、准确性好,可用于该制剂中盐酸麻黄碱和马来酸氯苯那敏的含量测定。Objective： To establish a method for the simultaneous determination of chlorphenamine maleate and ephedrine hydrochloride in chlorphenamine maleate and ephedrine nasal drops by HPLC. Methods： An HPLC method was performed on a column of PurospherSTAR RP18（ 150 mm × 4. 6 mm,5 μm） with the mobile phase of acetonitrile-potassium dihydrogen phosphate buffer（ p H3. 0 ± 0. 1）（ 18∶ 82 v / v） at the detection wavelength of 210 nm（ adjusting the flow rate and column temperature to 1. 0 ml·min^-1and35℃,respectively）. The injection volume was 20 μl. Results： A good linear relationship was established between the peak response and the concentration of ephedrine hydrochloride and chlorphenamine maleate over the range of 19. 81-118. 85 μg·ml^-1（ r = 0. 999 6）and 6. 21-37. 25 μg·ml^-1（ r = 0. 999 8）,respectively. The mean recovery of ephedrine hydrochloride and chlorphenamine maleate was 100. 39%（ RSD = 0. 69%,n = 9） and 100. 11%（ RSD = 0. 60%,n = 9）,respectively. Conclusion： The proposed method shows high repeatability,good durability and promising accuracy. It can be employed for the determination of two components in chlorphenamine maleate and ephedrine nasal drops.

关 键 词：扑麻滴鼻液 高效液相色谱法 盐酸麻黄碱 马来酸氯苯那敏 

分 类 号：R927.2[医药卫生—药学]