HPLC-ELSD检测系统测定注射用卵磷脂主要组分的含量

Determination of major components in ovolecithin for injection by HPLC-ELSD

目的 :采用高效液相色谱 -蒸发光散射 (HPLC -ELSD)检测系统测定注射用卵磷脂主要组分的含量。方法 :采用Nova -pakSilica径向柱 ,流动相 :A ,ψ(正己烷 ∶异丙醇 ) =6.5 ∶ 8;B ,ψ(正己烷 ∶异丙醇∶水 ) =6.5∶ 8∶ 1.5 ,梯度洗脱 ,蒸发光散射检测 ,检测器漂移管温度 :3 3℃ ,雾化气 :氮气 ,载气压力 :2 .5× 10 -5Pa。结果 :同时测定了注射用卵磷脂主要组分的含量。磷脂酰乙醇胺(PE)的平均回收率为 10 0 .6% ,RSD为 0 .72 % ,n =6;磷脂酰胆碱 (PC)的平均回收率为 10 0 .2 % ,RSD为 0 .43 % ,n =6。组分峰面积的自然对数与相应的浓度的自然对数呈良好的线性关系 ,线性范围PE为 2 5 4.4～ 5 93 .6μg/mL、PC为 2 44 2 .0～ 5 698.0 μg/mL。结论 :本法准确、灵敏、快捷、稳定性和重现性好 。

Objective:To establish a HPLC ELSD method to determine the content of compositions of ovolecithin for injection. Method: The HPLC ELSD system consisted of Nova pak Silica column,and a mixture of ψ (n Hexane ∶2 propanol)=6.5∶ 8 was used as mobile phase A,a mixture of ψ (n Hexane ∶2 propanol∶water)6.5∶8∶1.5  as mobile phase B,eluted in gradient mode. An Evaporative Light Scattering Detector was used,with the detector temperature:of 33 ℃,the nebulizing gas of N 2 and the pressure of 2.5×10 -5 Pa. Results: The content of major components in ovolecithin for injection were simulteneously determined. The average recovery for PE was 100.6%, RSD=0.72%,n =6,and the average recovery for PC was 100.2%, RSD=0.43%,n =6. The linear response was calculated by natural logarithm. The calibration curves were linear in the range of 254.4～593.6 μg/mL for PE and 2442.0～5698.0 μg/mL for PC. Conclusions: The method was found to be accurate,sensitive and rapid,with good stability and good reproducibility,and can be used for quality control of ovolecithin for injection.