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:PurospherSTAR 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 PurospherSTAR 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.
出处
《中国药师》
CAS
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)
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
Chlorphenamine maleate and ephedrine nasal drops
HPLC
Ephedrine hydrochloride
Chlorphenamine maleate