HPLC法测定酒石酸布托啡诺注射液的含量

摘要

目的 建立酒石酸布托啡诺注射液的含量测定方法.方法 采用高效液相色谱法,应用DI-ONEX-C18色谱柱(150 mm×4.6 mm,5μm),乙腈-0.05 mol/L磷酸二氢钾(25:75)为流动相；流速:1.0 mL/min；柱温:25℃；检测波长:282 nm.结果 酒石酸布托啡诺在25.5 ～ 510.0μg/mL具有良好的线性关系(r=0.999 7)；平均回收率为99.90％,RSD为1.20％(n=9).结论 本方法简便、快速准确,可作为该制剂质量控制方法.%Objective To establish a method for determining the content of butorphanol tartrate injection. Methods HPLC method was used with a DIONEX-C18( 150 mm×4. 6 mm,5 μm)column. The mobile phase consisted of acetonitrile -0. 05 mol/L potassium dihydrogen phosphate(25: 75). The flow rate was 1. 0 mL/min. The detection wavelength was set at 282 nm. The chromatography was conducted at 25℃. Results The calibration curve was in good linearity within the range of 25. 5 ~ 510. 0 μg/mL( r = 0. 999 7) ,the average recovery rate was 99. 90% ,RSD was 1. 20% . Conclusion The method is simple and rapid. It can be used to determine the butorphanol tartrate in this preparation.