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目的:建立前列地尔注射液中溶血磷脂酰胆碱含量测定的新方法。方法:采用硅胶柱(二羟基丙基键合硅胶为填充剂),以正庚烷-异丙醇-水(29.5∶59∶11.5)为流动相A,以正庚烷-异丙醇(43∶57)为流动相B,进行梯度洗脱,流速为1.0 mL·min-1,蒸发光散射检测器(飘移管温度60℃,载气流量3.2 L·min-1),柱温为35℃。结果:溶血磷脂酰胆碱进样量在0.2~1.8μg(r=0.9995)范围内,线性关系良好;平均回收率(n=9)为100.2%;重复性、专属性、供试品溶液的稳定性良好,辅料对测定无干扰。结论:经方法学验证,该方法专属性强、灵敏度高、准确度好,可以作为替代前列地尔注射液中溶血磷脂酰胆碱含量测定的方法。
Objective: To establish a new method for the determination of lysophosphatidylcholine in alprostadil injection. METHODS: Silica gel column (dihydroxypropyl-bonded silica as filler) was used as the mobile phase A in n-heptane-isopropanol-water (29.5:59:11.5) : 57) as mobile phase B, the gradient elution was carried out at a flow rate of 1.0 mL · min-1. The evaporative light scattering detector (drift tube temperature 60 ℃, carrier gas flow rate 3.2 L · min-1) . Results: The linear range of lysophosphatidylcholine was 0.2 ~ 1.8μg (r = 0.9995). The average recoveries (n = 9) were 100.2%. The reproducibility and specificity Stability is good, accessories without interference on the determination. Conclusion: The method is validated by the method and has the advantages of high specificity, high sensitivity and good accuracy, and can be used as a method for determining the content of lysophosphatidylcholine in the alprostadil injection.