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醋酸地塞米松静注乳剂的含量测定

Content determination of intravenous emulsion for dexamethasone acetate

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【作者】 徐晴皎; 全东琴;

【Author】 XU Qing-jiao, QUAN Dong-qin ( The People’s Hospital of Muping County,Yantai,264100; Institute of Pharmacology and Toxicology, Academy of Military Medical Sciences,Beijing, 100850)

【机构】 山东牟平人民医院药剂科; 军事医学科学院毒物药物研究所 烟台; 264100; 北京; 100850;

【摘要】 目的:建立醋酸地塞米松静注乳剂的含量测定方法。方法:采用C18色谱柱(4.60cm×25cm,10μm),流动相为水(含0.164mol/L磷酸,用三乙胺调pH值至3.5)-乙腈(43:57),以甲磺酸酚妥拉明为内标。结果:醋酸地塞米松量在1.84μg/mL-46.0μg/mL时,与峰面积比值呈良好线性,回归方程为A比=0.0868C+0.00885(r=0.9999,n=6),方法的日内与日间精密度RSD均小于2%,回收率分别为100.1%,98.7%和99.8%。结论:该方法快速准确、精密,可以用于该制剂的含量测定及稳定性分析。

【Abstract】 Objective:A HPLC method of content determination of intravenous emulsion for dexamethasone acetate was established. Methods:A ODS column was used and the mixture of acetonitrile-water (including 0.164mol/L phosphate,adjust pH3.5 with triamine). Results:The linearity between concentrations and peak area ratio was obtained from 1.84μg/mL to 46.0 μg/mL.The within-day and between-days variation coefficients were less than 2%(n=5).The average recoveries were 100.1% ,98.7%and 99.8% .respectively.Conclusion:The method was found to be rapid, accurate and precise. It is suitable for content and stability study.

  • 【文献出处】 中国药物应用与监测 ,Chinese Journal of Drng Application and Monitoring , 编辑部邮箱 ,2004年03期
  • 【分类号】R927
  • 【被引频次】2
  • 【下载频次】124
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