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目的建立羟基喜树碱(10-hydroxycamptothecin,HCPT)人血清白蛋白纳米粒(human serum al-bumin nanoparticle,HSA-NP)中药物含量的测定方法。方法采用Kromasil C18色谱柱(250 mm×4.6 mm,5μm),流动相为甲醇-水(体积比45∶55),流速1.0 mL.min-1,紫外检测波长266 nm,柱温35℃。结果在本实验条件下制剂中辅料对HCPT含量的测定无干扰,HCPT质量浓度在2.0~10.0 mg.L-1内线性关系良好(r=0.999 9,n=5),HCPT平均加样回收率为100.2%,RSD为1.0%(n=9)。结论本法准确可靠、简便易行,可用于羟基喜树碱人血清白蛋白纳米粒(HCPT-HSA-NP)中药物含量的测定。
OBJECTIVE To establish a method for the determination of the content of 10-hydroxycamptothecin (HCPT) human serum albumin nanoparticles (HSA-NP) in human serum. Methods Kromasil C18 column (250 mm × 4.6 mm, 5 μm) was used. The mobile phase was methanol-water (volume ratio 45:55). The flow rate was 1.0 mL.min-1. The UV detection wavelength was 266 nm. Results The excipients in this study did not interfere with the determination of HCPT content. The HCPT concentration ranged from 2.0 to 10.0 mg.L-1 (r = 0.999 9, n = 5), and the average recoveries of HCPT Was 100.2% with a RSD of 1.0% (n = 9). Conclusion This method is accurate and reliable, simple and easy to use, and can be used for the determination of the content of hydroxycamptothecin human serum albumin nanoparticles (HCPT-HSA-NP).