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

Determination of poloxamer 188 in paclitaxel lipid emulsion injections by GPC-ELSD

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UltrahydrogelTM（7.8 mm×300 mm,250）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20μL。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0.8μg;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 UltrahydrogelTMcolumn（ 7. 8 mm × 300 mm,250 ） with the mobile phase consisting of acetonitrile- water（ 20∶ 80）. The flow rate was 1. 0 mL·min- 1and the injection volume was 20μL. 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.