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目的:建立HPLC-ELSD测定尼莫地平脂肪孔注射液中溶血磷脂酰胆碱(LPC)的含量。方法:采用Kromasil 100-5SIL(250 mm×4.6 mm,5μm)色谱柱,以甲醇-冰醋酸(500:10,三乙胺调节pH至6.0)为流动相,流速为1.0 ml·min~(-1),柱温为30℃,使用蒸发光散射检测器(雾化气:氮气,漂移管温度:60℃)。结果:样品中磷脂酰胆碱(PC)及LPC与相邻杂质峰分离效果良好;LPC定量限为218.2 ng,检测限为65.46 ng;平均回收率为100.9%,RSD为3.3%(n=9)。结论:本法简便、专属性强、准确可靠,可用于尼莫地平脂肪乳注射液中溶血磷脂酰胆碱的含量测定。
Objective: To establish HPLC-ELSD to determine the content of lysophosphatidylcholine (LPC) in nimodipine fat-hole injection. Methods: The mobile phase was Kromasil 100-5SIL (250 mm × 4.6 mm, 5 μm) with methanol-glacial acetic acid (500:10 and triethylamine adjusted to pH 6.0) at a flow rate of 1.0 ml · min ~ (- 1) at a column temperature of 30 ° C using an evaporative light scattering detector (atomizing gas: nitrogen, drift tube temperature: 60 ° C). Results: The separation of phosphatidylcholine (PC) and LPC from adjacent impurities was good. The LPC limit of quantification was 218.2 ng with a detection limit of 65.46 ng. The average recovery was 100.9% with a RSD of 3.3% (n = 9) ). Conclusion: This method is simple, specific, accurate and reliable, and can be used for the determination of lysophosphatidylcholine in nimodipine fat emulsion injection.