HPLC法测定依托咪酯脂肪乳注射液的含量

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。

Determination of the content of etomidate fat emulsion injection by HPLC

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.