高效液相色谱法测定复方异维倍克气雾剂中异丙托溴铵和盐酸克仑特罗的含量  

HPLC Determination of Ipratropine and Clenbuterol Hydrochloride in Compound Yiweibeike Aerosol

作　　者：谭生建[1] 张启明[2] 刘刚[1] 姜韧[1] 薛克昌[1] 闵庆旺[1] 

机构地区：[1]解放军306医院药剂科,北京100101 [2]中国药品生物制品检定所,北京100050

出　　处：《药物分析杂志》2005年第9期1070-1072,共3页Chinese Journal of Pharmaceutical Analysis

摘　　要：目的:建立高效液相色谱法测定复方异维倍克气雾剂中异丙托溴铵和盐酸克仑特罗含量。方法:采用反相高效液相色谱法。Intersil C_(18)分析色谱柱(4.6 mm×250 mm,5μm),流动相为乙腈-水(16:84;含0.4%三乙胺,磷酸调 pH 为3),流速1.5 mL·mL^(-1),检测波长205 nm。结果:异丙托溴铵和盐酸克仑特罗的理论板数分别为2400和3500。异丙托溴铵回归方程Y=128458X+58038,r=0.9999,线性范围18.20～182.0μg·mL^(-1);盐酸克仑特罗回归方程 Y=1251564X+10954,r=0.9995,线性范围9.200～46.00μg·mL^(-1)。异丙托溴铵平均回收率为97.4%(n=5),RSD 为2.2%;盐酸克仑特罗平均回收率为100.8%(n=5),RSD为1.9%。异丙托溴铵和盐酸克仑特罗最低检出浓度分别为0.2μg·mL^(-1)和0.03μg·mL^(-1)。结论:方法简便,结果准确。Objective：A quantitative method was developed for the determination of ipratropine and clenbuterol hydrochloride in compound Yiweibeike aerosol by HPLC. Method： Ipratropine and clenbuterol hydrochloride were chromatographed on a Intersil C18 column（ 4.6mm×250mm,5μm）using a mixture of acetonitrile and water（ 16： 84）, which was adjusted to pH 3 by 0. 4 % triethylamine solution and phosphoric acid, and monitored at 205 nm with a flow rate of 1.5 mL·min ^- 1. Results： The number of theoretical plates of ipratropine and clenbuterol hydrochloride was 2400 and 3500 respectively. The regression equation of ipratropine was Y = 128458X ＋ 58038 （ r = 0. 9999） ,which was linear over a range from 18.20μg·mL^-1 to 182. 0μg·mL^-1. The regression equation of clenbuterol hydrochloride was Y = 1251564X ＋ 10954 （r = 0. 9995 ）, which was linear over a range from 9. 200μg·mL^-1 to 46. 00μg·mL^-1. The average recovery of ipratropine and clenbuterol hydrochloride was 97.4% （ n = 5, RSD 2.2% ） and 100.8% （n = 5, RSD 1.9% ） respectively. The measurable lowest limit were 0. 2μg·mL^-1 and 0. 03μg·mL^-1 respectively. Conclusion：The method is sensitive, rapid and accurate.

关 键 词：高效液相色谱法 复方异维倍克气雾剂 异丙托溴铵 盐酸克仑特罗 反相高效液相色谱法 气雾剂 含量 复方 测定 平均回收率 

分 类 号：R927.2[医药卫生—药学] R155.55