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目的建立测定多西紫杉醇脂质体中药物含量方法。方法采用Dikma ODS柱(4.6 mm×200 mm,5μm,Dikma);流动相:乙腈–水(50∶50,V∶V);柱温:室温;流速:1 mL·min-1;检测波长:230 nm。结果在本色谱条件下多西紫杉醇与辅料及溶剂峰分离良好,多西紫杉醇在5.05~40.4 mg·L-1内线性关系良好(r=1.000 0,n=5),回收率在98.8%~101.5%内,日内RSD及日间RSD均小于2%(n=3)。结论方法准确可靠、简单快速,可用于多西紫杉醇脂质体含量测定。
Objective To establish a method for the determination of docetaxel liposomes in the drug content. The method was performed on a Dikma ODS column (4.6 mm × 200 mm, 5 μm, Dikma). The mobile phase consisted of acetonitrile-water (50:50, V:V). The column temperature was at room temperature and the flow rate was 1 mL · min- 230 nm. Results The docetaxel was well separated from its excipients and solvent peaks under this chromatographic condition. Docetaxel showed good linearity (r = 1.000 0, n = 5) in the range of 5.05-40.4 mg · L-1 and the recovery rate was 98.8% Within 101.5%, intraday RSD and intraday RSD were less than 2% (n = 3). Conclusion The method is accurate, reliable, simple and rapid and can be used to determine the content of docetaxel liposomes.