HPLC法测定依托泊苷亚微乳中的药物含量

Determination of etoposide in the submicron emulsions by HPLC

目的:采用高效液相色谱法测定依托泊苷亚微乳中依托泊苷的含量。方法:采用盐破乳,混合溶剂提取药物的方法,实现药物与亚微乳中油脂的分离,用甲醇定容后高效液相色谱法测定亚微乳中依托泊苷的含量。色谱条件:色谱柱:InertsilODS-3柱(250mm×4.6mm,5μm);流动相:乙腈-pH值4.0醋酸盐缓冲液(32∶68);流速:1.0mL.min-1;柱温:30℃;检测波长:285nm。结果:依托泊苷亚微乳中其他物质对依托泊昔的测定无干扰,在0.80～40.0μg.mL-1范围内线性关系良好(r=0.9999),平均回收率为98.9%,重复性和稳定性良好。结论:本法去除了亚微乳中的油脂,保护了色谱柱,适用于依托泊苷亚微乳的长期质量控制。

Objective：To establish an HPLC method for assaying etoposide in the submicron emulsions. Methods：The submicron emulsions were demulsified by anhydrous sodium sulfate and a mixed solvent was used to extract etoposide from the submicron emulsions. The chromatographic separation was performed on inertsil ODS-3 column （250 mm× 4.6 mm, 5μm） at 30℃. The mobile phase consisted of acetonitrile and pH4.0 acetate buffer solution （32：68 ）. The flow rate was set at 1.0 mL. min^-1, and detection at 285 nm. Results ： The calibration range was from 0.80 to 40.0μ mL6-1. The recovery was 98.9%. Concluslon：The method can be used for assaying etoposide in the submicron emulsions.