HPLC法测定米铂脂质体中米铂的含量

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 C₈色谱柱（250 mm×4.6 mm，5 μm），以甲醇-水（92∶8）为流动相，流速1.0 mL·min^-1，检测波长210 nm，柱温30℃，进样量20 μL。结果：色谱分离度R=2.91，阴性对照无干扰；米铂在3.37~115.11 μg·mL^-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 mL·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。

Objectives: To establish an HPLC method for the quantification of miriplatin in miriplatin-loaded liposomes (lipomiriplatin).Methods: The detection was performed on an Agilent C₈ column (250 mm×4.6 mm, 5 μm) at 210 nm.An isocratic elution was used with methanol and water (92:8) as the mobile phase at a flow rate of 1.0 mL·min^-1.Results: The method was validated:with a resolution of 2.91;linear, in the range of 3.37-115.11 μg·mL^-1(r=0.999 9) and accurate, with the average recovery rate of 97.1% (RSD=0.90%, n=3)、97.0% (RSD=0.10%, n=3) and 98.7% (RSD=0.59%, n=3) at low, medium and high concentrations;precision, inter-day and intra-day precision reflected by the relative standard deviation(RSD) values of 0.75% (n=6) and 1.0% (n=6) respectively, robust under slight change of flow rate (0.99-1.01 mL·min^-1) and column temperature (28-32℃) with RSD of 0.49% (n=9) and 1.7% (n=9), respectively.Conclusion: A simple, selective, sensitive and robust HPLC method has been established for the determination of miriplatin loaded in lipomiriplatin.