HPLC法测定注射用多西他赛纳米粒中溶血磷脂酰胆碱含量

目的：建立高效液相色谱法测定注射用多西他赛纳米粒中溶血磷脂酰胆碱含量。方法：采用Xtimate C₁₈（4.6 mm×250 mm，5 μm）色谱柱，以0.08 mol·L^-1磷酸二氢钾水溶液（A）-乙腈（B）为流动相进行梯度洗脱（0~20 min，50%B；20~22 min，50%B→70%B；22~32 min，70%B；32~34 min，70%B→50%B；34~50 min，50%B），流速1.2 mL·min^-1，柱温35 ℃，紫外检测波长210 nm。结果：在选定条件下，溶血磷脂酰胆碱与样品其他组分分离良好，溶血磷脂酰胆碱峰面积与浓度在0.03~0.25 mg·L^-1 范围内具有良好线性关系，r=0.9997；检测限0.2 μg，定量限0.4 μg；平均回收率在99%~105%，RSD<6%。结论：经方法学验证表明，该方法可用于注射用多西他赛纳米粒中溶血磷脂酰胆碱含量测定。

Objective: To establish an HPLC method for determining lysophosphatidylcholine in nanoparticles of docetaxel for injection. Methods: The separation was performed on the Xtimate C₁₈ column (4.6 mm×250 mm,5 μm),the mobile phase consisted of 0.08 mol·L^-1 potassium dihydrogen phosphate (A) and acetonitrile (B) with a gradient elution (0-20 min,50%B;20-22 min,50%B→70%B;22-32 min,70%B;32-34 min,70%B→50%B;34-50 min,50%B) at a flow rate of 1.2 mL·min^-1.The column temperature was 35 ℃,and the detection wavelength was at 210 nm. Results: Under the described condition,lysophosphatidylcholine was completely separated from other components in nanoparticles of docetaxel for injection.Good linear relationship was observed between the peak area of lysophosphatidylcholinethe and concentration in the range of 0.03-0.25 mg·L^-1 ,r=0.9997.The limit of detection was 0.2 μg,and the limit of quantitation was 0.4 μg.The average recovery of lysophosphatidylcholine ranged from 99% to 105%.The relative standard deviations were less than 6%. Conclusion: It is confirmed by the methodology validation that the quantification method is applicable to the quality control of lysophosphatidylcholine in nanoparticles of docetaxel for injection.