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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×250mm,5μm)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;20~22min,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0.2μg,定量限0.4μg;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 a method for the determination of lysophosphatidylcholine in docetaxel nanoparticles for injection by high performance liquid chromatography. Methods: The gradient elution was carried out on a Xtimate C18 (4.6 mm × 250 mm, 5 μm) column with a mobile phase of 0.08 mol·L-1 potassium phosphate monobasic (A) -acetonitrile (0 to 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, column temperature 35 ℃, UV detection wavelength 210 nm. Results: Under the selected conditions, the lysophosphatidylcholine was separated from other components of the sample. The peak area of lysophosphatidylcholine had a good linear relationship with the concentration of 0.03 ~ 0.25 mg · L-1, r = 0.9997. The detection limit of 0.2μg, the limit of quantification 0.4μg; average recovery of 99% to 105%, RSD <6%. Conclusion: The methodological validation shows that this method can be used to determine the content of lysophosphatidylcholine in docetaxel nanoparticles for injection.