HPLC法同时测定复方麻黄碱滴鼻液中4个组分的含量  

HPLC simultaneous determination of four components in compound ephedrine hydrochloride nasal drops

作　　者：沈国荣[1] 钱美英[1] 缪丽燕[1] 王尧[1] 

机构地区：[1]苏州大学附属第一医院,苏州215006

出　　处：《药物分析杂志》2006年第11期1637-1639,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立高效液相色谱法同时测定复方麻黄碱滴鼻液中4个组分的含量。方法:采用 Kromasil C_(18)(150 mm×4.6mm,5 μm)色谱柱,柱温为室温,流动相为0.05 mol·L^(-1)磷酸二氢钾-甲醇(45:55,pH 4.0),流速1.0 mL·min^(-1),检测波长为257 nm。结果:盐酸麻黄碱、盐酸苯海拉明、醋酸氯己定和地塞米松磷酸钠分别在12.5～400 μg·mL^(-1)(r=0.9999),2.5～80 μg·mL^(-1)(r=0.9996),1.25～40 μg·mL^(-1)(r=0.9998),0.375～12 μg·mL^(-1)(r=0.9997)浓度范围内线性关系良好;4个组分的低、中、高3个不同浓度的平均回收率范围为94.07%～100.9%,RSD 为0.61%～4.4%。结论:本法操作简便,结果准确,可用于复方麻黄碱滴鼻液中4个组分含量的同时测定。Objective： To establish a method for simultaneous determination of ephedrine hydrochloride, diphenhydramine hydrochloride, chlorhexidine acetate and dexamethasone sodium phosphate by HPLC. Methods： The HPLC method was performed with Kromasil C18 column（ 150 mm × 4. 6 mm,5 μm）, and the column temperature was room temperature, the mobile phase consisted of 0. 05 mol · L^- 1 KH2 PO4 - methanol （ 45 ： 55, pH 4. 0）, at a flow rate of 1.0 mL· L^- 1 . The UV detective wavelength was 257 nm. Results：The linear range was 12.5 -400 μg · mL^-1 （ r = 0. 9999 ） for ephedrine hydrochloride, 2. 5 - 80 μg · mL^-1 （ r = 0. 9996 ） for diphenhydramine hydrochloride, 1.25 -40 μg · mL^-1 （ r = 0. 9998 ） for chlorhexidine acetate,0. 375 - 12 μg · mL^-1 （ r = 0. 9997 ） for dexamethasone sodium phosphate,the average recoveries and RSD of four components ranged from 94. 07% to 100. 9% and 0.61% to 4. 4% respectively. Conclusions：The method is accurate,simple,and can be used for simultaneous determination of the four components in nasal drops.

关 键 词：高效液相色谱法 盐酸麻黄碱 盐酸苯海拉明 醋酸氯己定 地塞米松磷酸钠 

分 类 号：R917[医药卫生—药物分析学]