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目的建立半乳糖化肝靶向葫芦素B脂质体中药物含量测定的方法,对制剂进行有效的质量控制。方法采用RP-HPLC法。色谱柱为Diamonsil C18柱(200 mm×4.6 mm,5μm),流动相为乙腈-水(体积比50∶50),流速1 mL.min-1,检测波长233 nm,柱温35℃。结果在本色谱条件下,半乳糖化肝靶向脂质体辅料对葫芦素B的测定无干扰,葫芦素B质量浓度在1.0~20 mg.L-1内与峰面积呈良好的线性关系(r=0.9999,n=5),葫芦素B平均回收率为100.6%,RSD为1.0%(n=9)。结论本法准确、可靠、简便、快速,可用于半乳糖化肝靶向葫芦素B脂质体中药物含量的质量控制。
Objective To establish a method for the determination of the content of cucurbitacin B liposomes in galactosylated liver and to control the quality of the preparation effectively. Methods RP-HPLC method. The column was Diamonsil C18 (200 mm × 4.6 mm, 5 μm). The mobile phase consisted of acetonitrile-water (volume ratio 50:50) with a flow rate of 1 mL · min-1. The detection wavelength was 233 nm and the column temperature was 35 ℃. Results Under the conditions of the chromatographic conditions, the galactosylated liver targeting liposome excipient had no interference on the determination of cucurbitacin B. The concentration of cucurbitacin B showed a good linear relationship with the peak area in 1.0 ~ 20 mg.L-1 r = 0.9999, n = 5). The average recovery of cucurbitacin B was 100.6% and the RSD was 1.0% (n = 9). Conclusion This method is accurate, reliable, simple and rapid and can be used for the quality control of the cucurbitacin B liposomes with galactosylated liver targeting.