HPLC-ELSD测定酒石酸长春瑞滨脂质体注射液中两降解物质

目的：建立HPLC-ELSD法测定酒石酸长春瑞滨脂质体注射液中两降解物质：磷脂酰胆碱（LPC）、磷脂酰乙醇胺（LPE）的含量。方法：采用Kromasil 100-5C4柱（250 mm×4.6 mm，5μm），以水为流动相A，以甲醇（含0.10%二乙胺）为流动相B，梯度洗脱；柱温：40℃，流速为1.0 mL·min-1，蒸发光散射检测器，检测器漂移管温度：50℃，气体流量：2.0 L·min-1。结果：酒石酸长春瑞滨脂质体注射液中LPC与LPE能很好地分离检出，其线性浓度范围分别为：0.02~0.30 mg·mL-1（r=0.9997）、0.01~0.04 mg·mL-1（r=0.9994），呈良好的线性关系，LPC 3种浓度平均加样回收率分别为99.9%、100.3%、98.9%。 RSD%分别为2.2%、0.5%、1.2%；LPE 3种浓度平均加样回收率分别为97.9%、96.6%、98.5%，RSD%分别为1.5%、0.7%、1.0%。结论：该方法简单、准确、重复性好，可用于本品中降解物质LPC和LPE的质量控制。

Determination of Lyso-phosphatidylcholine and Lyso-phosphatidylethanolamine in Vinorelbine Tartrate liposome injection by HPLC-ELSD

Objective: To establish an HPLC -ELSD method for the determination of lyso -phosphatidylcholine (LPC) and lyso -phosphatidylethanolamine (LPE) in vinorelbine tartrate liposome injections. Methods: Compounds were separated by a kromasil 100-5C4 (250 mm ×4.6 mm, 5μm) column with water as mobile phase A and methanol (containing 0.10% diethylamine) as mobile phase B. The column temperate was kept at 50 ℃. The flow rate was 1.0 mL·min-1. The detection was done by an evaporate light-scattering detector (ELSD) with the drift tube temperate at 50℃ and the flow rate of carrier gas air at 2.0 L·min-1. Results: The linear response was achieved by natural logarithm transform of data. Separation was very good for LPC and LPE in vinorelbine tartrate liposome injections. The calibration curves were linear in the range of 0.02-0.30 mg·mL-1 for LPC (r=0.9997) and 0.01-0.04 mg·mL-1 for LPE (r=0.9994). The average recoveries for LPC at 3 levels were 99.9%, 100.3% and 98.9% with RSD at 2.2%, 0.5% and 1.2%; and those for LPE were 97.9%, 96.6% and 98.5% with RSD at 1.5%, 0.7% and 1.0%. Conclusion: The method is simple, accurate and reproducible. It can be used for the quality control of LPC and LPE in vinorelbine tartrate liposome injections.