摘要
目的建立咪达唑仑注射液中依地酸二钠含量的HPLC检测方法。方法采用Agela Venusil MP C18柱(4.6 mm×250 mm,5μm),梯度洗脱流动相A为0.4%四丁基氢氧化铵溶液(取40%四丁基氢氧化铵溶液13 mL,加水1440 mL,混匀,用磷酸调节pH值至7.4)-甲醇-乙腈(82∶16∶2),B为水-甲醇(20∶80),流速为1.0 mL·min-1,检测波长为254 nm。结果依地酸二钠溶液在0.5032~50.32μg·mL-1与峰面积呈线性关系(r=1.000),平均回收率在99.6%~103.1%,RSD均<2.0%。结论本方法简便、准确,可用于咪达唑仑注射液中依地酸二钠的含量测定。
Objective To develop an HPLC method to determine disodium edetate in midazolam injection.Methods The Agela Venusil MP C18 column(4.6 mm×250 mm,5μm)was used.The mobil phase A was 0.4%tetrabutylammonium hydioxide solution(pH 7.4 adjusted by phosphoric acid)-methonal-acetonitrile(82∶16∶2)and the mobile phase B was composed of aqueous-methonal(20∶80)at a flow rate of 1.0 mL·min-1.The detection wavelength was 254 nm.Results The analytical curve was linear at 0.5032-50.32μg·mL-1(r=1.000),the average recovery was at 99.6%-103.1%,and the RSDs were less than 2.0%.Conclusion The method is rapid and simple,which can be used for the content determination of disodium edetate in midazolam injection.
作者
姚枝玉
黄朝瑜
蔡美明
陈民辉
YAO Zhi-yu;HUANG Chao-yu;CAI Mei-ming;CHEN Min-hui(Jiangsu Insitite for Food and Drug Control,Nanjing 210019)
出处
《中南药学》
CAS
2020年第1期102-104,共3页
Central South Pharmacy
