凝胶色谱-蒸发光散射检测法测定紫杉醇脂肪乳注射液中泊洛沙姆188的含量

目的：建立凝胶色谱-蒸发光散射检测法（GPC-ELSD）测定紫杉醇脂肪乳注射液中泊洛沙姆188的含量。 方法：采用Ultrahydrogel^TM（7.8 mm×300 mm，250 Å）水性凝胶柱，以乙腈-水（20：80）为流动相，流速1.0 mL·min^-1，蒸发光散射器的漂移管温度为50℃，载气流速为1.9 L·min^-1，进样量20 μL。 结果：泊洛沙姆188浓度在0.4~1.2 mg·mL^-1范围内线性关系良好（r=0.9998）；定量限为0.8 μg；泊洛沙姆188的平均回收率（n=9）为101.6%，RSD为0.65%；脂肪乳中的其他成分对检测没有干扰。 结论：该检测方法经方法学验证，适用于紫杉醇脂肪乳注射液中泊洛沙姆188的含量测定。

Objective: To establish a method for determination of the concentration of poloxamer 188 in paclitaxel lipid emulsion injections by gel permeation chromatography-evaporative light scattering detector(GPC-ELSD). Methods: The separation was performed on an Ultrahydrogel^TM column(7.8 mm×300 mm,250 Å)with the mobile phase consisting of acetonitrile-water(20: 80).The flow rate was 1.0 mL·min^-1 and the injection volume was 20 μL.The drift tube temperature of the ELSD was set at 50℃,and the gas flow rate was 1.9 L·min^-1. Results: Under the above described condition,the linear concentration range of poloxamer 188 was 0.4-1.2 mg·mL^-1(r=0.9998).The detection limit was 0.8 μg for Poloxamer 188.The average recovery rate(n=9) was 101.6%,and the RSD was 0.65%.There was no influence of other ingredients on the determination. Conclusion: The methodology validation shows that the established method is suitable for the determination of poloxamer 188 in paclitaxel lipid emulsion injections.

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