HPLC-ELSD法测定前列地尔注射液中溶血磷脂酰胆碱的方法改进

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0.2~1.8 μg（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 develop a new method for lysophosphatidycholine (LCP) determination of alprostadil injection. Methods: The assay was carried out on a Silica gel column (dihydroxypropyl bonded silica as a filler) with the mobile phase of n-heptane-isopropanol-water(29.5: 59: 11.5)and n-heptane-isopropanol(43: 57) at a gradient with a flow rate of 1.0 mL·min^-1.The column temperature was 35℃.The drift tube temperature of the evaporative light scattering detector was 60℃ and the carrier gas flow rate was 3.2 L· min^-1. Results: The linear range of lysophosphatidycholine was good between 0.2-1.8 μg(r=0.9995),and the average recovery was 100.2% (n=9);the repeatability,specificity,stability of the test solution were good,and there was no interference among the components. Conclusion: The new HPLC method is good in the aspect of selectivity,sensitivity and accuracy,and can be used to replace the detection method for lysophosphatidycholine in alprostadil injection.

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