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目的:建立米铂脂质体中米铂的含量测定方法。方法:采用HPLC法测定米铂脂质体中米铂的含量。色谱条件:采用Agilent C_8色谱柱(250 mm×4.6 mm,5μm),以甲醇-水(92∶8)为流动相,流速1.0m L·min~(-1),检测波长210 nm,柱温30℃,进样量20μL。结果:色谱分离度R=2.91,阴性对照无干扰;米铂在3.37~115.11μg·m L~(-1)范围内线性关系良好(r=0.999 9);低、中、高3种浓度的平均回收率分别为97.1%(RSD=0.90%,n=3)、97.0%(RSD=0.10%,n=3)和98.7%(RSD=0.59%,n=3);日内精密度RSD=0.75%(n=6),日间精密RSD=1.0%(n=6);流速在0.99~1.01 m L·min~(-1)范围内变化时RSD=0.49%(n=9),柱温在28~32℃之间变化时RSD=1.7%(n=9)。结论:本文建立的方法简便易行,稳定,准确,专属性强,耐用性好;可定量检测米铂脂质体中米铂的含量。
Objective: To establish a method for the determination of moplatin in moplatin liposomes. Methods: The content of moplatin in moplatin liposomes was determined by HPLC. Chromatographic conditions: The mobile phase consisted of an Agilent C_8 column (250 mm × 4.6 mm, 5 μm) with a mobile phase of methanol-water (92: 8) at a flow rate of 1.0 mL · min -1 and a detection wavelength of 210 nm. 30 ℃, injection volume 20μL. Results: The chromatographic resolution was 2.91, no interference was observed in the negative control. The linear relationship was found in the range of 3.37-115.11 μg · m L -1 (r = 0.999 9) The average recovery was 97.1% (RSD = 0.90%, n = 3), 97.0% (RSD = 0.10%, n = 3) and 98.7% (RSD = 0.59%, n = 3) RSD = 0.49% (n = 9) when the flow rate was in the range of 0.99 ~ 1.01 m L · min ~ (-1), the column temperature RSD = 1.7% (n = 9) at 28 ° C to 32 ° C. Conclusion: The method established in this paper is simple, stable, accurate, specific and durable, and can quantitatively detect the content of moplatin in the moplatin liposomes.