高效液相色谱法测定流感病毒裂解疫苗中Triton X-100的含量

HPLC determination of triton X-100 in (Split,Inactivated) Influenza Vaccine

目的:建立流感病毒裂解疫苗中裂解剂Triton X-100含量的HPLC法。方法:采用SymmetryShieldTM RP18色谱柱(4.6 mm×250 mm,5μm),以注射用水-无水甲醇(20∶80)为流动相,流速为1.5 mL.min-1,柱温为25℃,检测波长为230nm,进样量为10μL,用面积归一法测定。结果:Triton X-100在625～39μg.mL-1范围内线性关系良好(r=0.9994),流感病毒裂解疫苗原液平均加样回收率为107.7%,RSD为0.3%;流感病毒裂解疫苗平均加样回收率为108.5%,RSD为0.4%。结论:本方法灵敏度高,操作简便可靠。

Objective： To establish a method for the determination of Triton X - 100 in Influenza Vaccine （ Split, Inactivated） by HPLC. Method： A Waters SymmetryShieldTM RP18 column （4.6 mm× 250 mm, 5 μm） was used with the mobile phase of injection water - methanol（20： 80） at flow rate of 1.5 mL ·min^-1. The column tempera- ture was 25 ℃ and the UV detection wavelength was 230 nm. Results： The Triton X- 100 curve was linear in the range of 625 to 39 μg · mL^-1 （ r =0. 9994）. The average recovery of Triton X - 100 in Influenza Vaccine buik was 107.7% （ RSD = 0.3% ）. The average recovery of Triton X - 100 in Influenza Vaccine was 108.5% （ RSD = 0. 4% ）. Conclusion ：The method is high sensitivity, simple and accurate.