HPLC-DAD法同时测定依托泊苷注射液中3个成分的含量  

Content determination of three compounds in etoposide injection by HPLC-DAD

作　　者：陈秋竹[1] 黄春青[1] 曹桂红[1] 何劼毅 CHEN Qiuzhu;HUANG Chunqing;CAO Guihong;HE Jieyi(Guizhou Institute for Food and Drug Control,Guiyang,Guizhou 550004,China)

机构地区：[1]贵州省食品药品检验所,贵州贵阳550004

出　　处：《贵州师范大学学报（自然科学版）》2022年第5期64-70,共7页Journal of Guizhou Normal University：Natural Sciences

基　　金：2019年国家药品标准提高项目(2019Z007)。

摘　　要：通过采用Waters X-Bridge C_(18)色谱柱,以流动相A:无水甲酸-三乙胺-水(1∶1∶998,V∶V∶V)和流动相B:无水甲酸-三乙胺-乙腈(1∶1∶998,V∶V∶V)进行梯度洗脱,流速1.0 mL/min,在检测波长254 nm、柱温为30℃的条件下,建立高效液相色谱法(HPLC)同时测定托泊苷注射液中依托泊苷、苯甲醇、苯甲醛含量的方法,为依托泊苷注射液的质量评价提供依据。结果表明,依托泊苷、苯甲醇和苯甲醛分别在0.2042~16.667μg(r^(2)=0.9999)、0.3264~8.160μg(r^(2)=1.00)、0.002297~0.2297μg(r^(2)=1.00)范围内线性关系良好;方法回收率分别为99.9%、100.7%、98.8%,RSD分别为0.7%、1.1%、3.4%。该方法简便、快速、重现性好,可用于依托泊苷注射液中依托泊苷、苯甲醇及苯甲醛3种化合物的含量测定分析。By using Waters X-Bridge C_(18) column,with mobile phase A:anhydrous formic acid-triethylamine-water(1∶1∶998,V∶V∶V)and mobile phase B:anhydrous formic acid-triethylamine-acetonitrile(1∶1∶998,V∶V∶V)for gradient elution at a flow rate of 1.0 mL/min,under the conditions of detection wavelength of 254 nm and column temperature of 30℃,a high-performance liquid chromatography(HPLC)method for simultaneous determination of etoposide,benzyl alcohol,and benzaldehyde in Etoposide injection was established.The linear ranges of etoposide,benzyl alcohol,and benzaldehyde were 0.2042~16.667μg(r^(2)=0.9999),0.3264~8.160μg(r^(2)=1.00),0.002297~0.2297μg(r^(2)=1.00)respectively.The average recoveries were 99.9%with RSD of 0.7%,100.7%with RSD of 1.1%and 98.8%with RSD of 3.4%respectively.The developed method is simple,rapid and reproducible,and can be used in quality control of Etoposide injection.

关 键 词：高效液相色谱 依托泊苷注射液 苯甲醇 苯甲醛 

分 类 号：R284.1[医药卫生—中药学] R927.2[医药卫生—中医学]