摘要
目的：提升依托咪酯脂肪乳注射液含量的检测方法。方法：采用高效液相法，色谱柱：大连伊利特Hypersil BDS C18（4.6 mm×250 mm×5μm）色谱柱；流动相：乙腈-0.01mol·L-1磷酸铵（含1%四丁基溴化铵，磷酸调PH=6.5）（50：50），等度洗脱；检测波长：243 nm；流速：1.0 mL·min-1；柱温：50℃。结果：依托咪酯与各杂质之间均达到良好分离；依托咪酯在160～240μg·mL-1范围内与峰面积呈良好的线性关系（r=0.9997），线性方程y=55.113x-103.4；方法的加样回收率（n=9）为99.8%，RSD为0.81%；依托咪酯检测限为0.18ng。结论：该法快速、简便、准确、重复性好，适用于依托咪酯脂肪乳注射液的质量控制。
Objective：To establish a HPLC method for the determination of Etomidate Fat Emulsion Injection.Method：The HPLC was carried out on a Hypersil BDS C18（250 mm×4.6 mm,5μm）column with a flow rate of 1.0 mL·min-1 at column temperature 50℃,of which the mobile phase was consisted of 0.01 mol·L-1 solution of ammonium phosphate（containing 1%of tetrabutylammonium bromide,PH was adjusted to 6.5 with phosphoric acid）buffer and acetonitrile（50∶50）and the detected UV wavelength was 243 nm. Results：The calibration curve was linear（r=0.9997）in the range of 160~240μg·mL-1 for etomidate,and the average recovery was 99.8%,with RSD 0.81%. The limit of detection was 0.18 ng for etomidate. Conclusion：It is an accurate,simple,rapid,qualitative method with good reproducibility for the determination of Etomidate Fat Emulsion Injection and its related substances.
出处
《福建分析测试》
CAS
2014年第2期32-34,共3页
Fujian Analysis & Testing
关键词
HPLC
依托咪酯
注射液
含量测定
有关物质
质量标准
HPLC
Etomidate
Injection
related substances
content determination
quality standard
作者简介
李志琴（1973-），女，工程师，从事制药分析工作。
通讯作者：赵艳霞。Email：xiaoxia0716xyz@163．com
