HPLC法测定氟哌利多注射液的含量

目的建立氟哌利多注射液含量测定的高效液相色谱法。方法Inertsil ODS-3柱;流动相:甲醇-硼酸盐缓冲液取硼酸31g,加水800mL,滴加氢氧化钠溶液(1→5)至硼酸完全溶解并调节pH值至7.0,加水至1000mL,混匀]-水(650∶20∶330);流速:1.0mL.min-1;检测波长:280nm。结果氟哌利多在10~100μg.mL-1范围内线性关系良好,r=1.0000,平均回收率为99.8%(n=9)。结论本法结果准确、重现性好,可用于氟哌利多注射液的质量控制。

Determination of droperidol in Droperidol Injection by HPLC

OBJECTIVE To establish an HPLC method for the determination of droperidol. METHODS A Inertsil ODS -3 column with UV detection at 280nm,and Methanol-Borate Buffer dissolve 31g of boric acid in about 800mL of water,add sodium hydroxide solution （1 in 5） in small quantities until all of the boric acid is dissolved and the pH is constant at 7. 0,dilute with water to 1000mL,mix well]-water（650 ： 20 ： 330） as the mobile phase were used. The flow rate was 1.0mL · min^-1 , and the temperature of the column was 35℃. RESULTS The calibration curve of droperidol was linear in the concentration range of 10-100μg · mL^-1. The average recovery was 99.8%（ n =9）. CONCLUSION The method was simple,and accurate with a good reproducibility and can be used for the quality control of Droperidol Injection.