HPLC-电喷雾检测器法测定长春瑞滨热敏脂质体中溶血磷脂含量

Determination of lysolipid in vinorelbine liposome for injection by HPLC-charged aerosol detector

目的：建立HPLC-电喷雾检测器检测长春瑞滨脂质体中单硬脂酰磷脂酰胆碱（MSPC）含量的方法并验证。方法：采用Waters e2695系列高效液相色谱系统联合电喷雾检测器进行测定。采用ZorbaxE—clipse Plus C18色谱柱，流动相为甲醇一水，梯度洗脱，流速1．0mL·min^-1。检测器参数：气压35psi（house nitrogen），量程200pA。结果：此方法线性范围为4．8～28．8μg·mL^-1（r=0．9999），重复性、中间精密度RSD均〈2．O％，平均回收率为100．43％。结论：本方法可以快速、简便的测定长春瑞滨热敏脂质体中MSPC的含量，灵敏度高，相应一致性好，充分说明了电喷雾检测器适于检测脂质体中的低浓度溶血磷脂。

Objective： To establish a high performance liquid chromatographic method with charged aerosol detection （HPLC-CAD） for the determination of MSPC in vinorelbine liposome for injection, and to validate this method. Methods： A Waters e2695 Series HPLC system equipped with a charged aerosol detector was used. The samples were injected into a Venusil XBP-C8 column. The mobile phase was composed of methanol and distilled water with a flow rate of 1.0 mL· min^ -1. The detector parameters included a gas pressure of 35 psi （house nitrogen） and a range of 200 pA. Results ： The calibration curves were linear between 4.8 - 28.8 μg· mL ^- 1 （ r = 0. 999 9）. The repeatability and the intermediate precision RSD were less than 2.0%. The average recovery was 100.43%. Conclusion： This method is accurate, repeatable, convenient and rapid for the determination of 1-myristoyl-2-stearoylsn-glycero-3-phosphatidylcholine （MSPC） in vinorelbine liposome for injection. The charged aerosol detector is competent in the determination of lysolipid at low concentration.