环糊精手性色谱柱HPLC同时测定酒石酸布托啡诺注射液中酒石酸布托啡诺及其右旋异构体和苄索氯铵的含量  

Simultaneous Determination of Butorphanol Tartrate,Dextroisomer and Benzethonium Chloride in Butorphanol Tartrate Injection on Cyclodextrin Chiral Column by HPLC

作　　者：裴琳 王立云 卢京光 王超 李新荣 PEI Lin WANG Li-yun LU Jing-guang WANG Chao LI Xin-rong(Qingdao Institute for Food and drug Control, Qingdao 266071, China)

机构地区：[1]青岛市食品药品检验研究院,山东青岛266071

出　　处：《中国药学杂志》2016年第19期1695-1698,共4页Chinese Pharmaceutical Journal

基　　金：国家药品标准提高行动计划资助项目([2010]2-273)

摘　　要：目的建立环糊精手性色谱柱HPLC同时测定酒石酸布托啡诺注射液中酒石酸布托啡诺、右旋异构体和抑菌剂苄索氯铵的含量。方法采用Astec CyclobondⅡ环糊精手性色谱柱(4.6 mm×250 mm,5μm),流动相:0.05 mol·L^(-1)醋酸铵溶液(冰乙酸调节pH值为4.1)(A)-乙腈(B)梯度洗脱;检测波长:280 nm;流速:1.0 mL·min^(-1);紫外检测器。结果 3种待测组分线性关系良好,酒石酸布托啡诺线性范围为0.04~2.0 mg·mL^(-1)(r=0.999 9),平均加样回收率为100.2%;右旋异构体线性范围为0.01~2.0 mg·mL^(-1)(r=1.000),平均加样回收率为100.7%;苄索氯铵线性范围为0.02~1.0 mg·mL^(-1)(r=0.999 9),平均加样回收率为99.4%。结论该方法简便、准确,重复性好,可用于酒石酸布托啡诺注射液的质量控制。OBJECTIVE To establish an HPLC method for the simultaneous determination of butorphanol tartrate, dextroiso- mer and benzethonium chloride which works as the bacteriostatic agent in butorphanol tartrate injection on a cyclodextrin chiral column. METHODS The HPLC analysis was performed on an Astec Cyelobond 11 eyelodextrin chiral column （4.6mm×250mm,5μm） , with mobile phase consisting of 0.05 mol · L-1 ammonium acetate solution （ pH was adjusted to 4. 1 by acetic acid） and acetonitrile using gradient elution at a flow rate of 1.0 mL· min-1. The detection wavelength was set at 280 nm. RE- SULTS The method showed good linearity for the three components to be measured. The linear ranges were 0.04 - 2.0 mg ·mL-1 for butorphanol tartrate （r =0. 999 9） , 0.01 -2.0 mg ·mL-1 for dextroisomer （r = 1. 000 0） , and 0.02 - 1.0 mg · mL-1 for benzethonium chloride （r = 0. 999 9） , respectively. The average recoveries were 100.2% , 100.7% , and 99.4% , respectively. CONCLUSION The method is simple, accurate and reproducible. It can be used for the quality control of butor- phanol tartrate injection.

关 键 词：高效液相色谱法 环糊精手性色谱柱 酒石酸布托啡诺 异构体 抑菌剂 苄索氯铵 

分 类 号：R917[医药卫生—药物分析学]