使用高通量亲水相互作用色谱-串联质谱法对血浆中的抗流感药物扎那米韦进行定量分析。

Quantification of the anti-influenza drug zanamivir in plasma using high-throughput HILIC-MS/MS.

作者信息

Lindegardh Niklas, Hanpithakpong Warunee, Kamanikom Benjamas, Farrar Jeremy, Hien Tran Tinh, Singhasivanon Pratap, White Nicholas J, Day Nicholas P J

机构信息

Faculty of Tropical Medicine, Mahidol University, Bangkok 10400, Thailand.

出版信息

Bioanalysis. 2011 Jan;3(2):157-65. doi: 10.4155/bio.10.189.

BACKGROUND

parenteral zanamivir is a promising drug for the treatment of severe influenza. However, quantification of this polar drug in biological matrices has traditionally been difficult and the methods developed have been relatively insensitive.

RESULTS

a high-throughput bioanalytical method for the analysis of zanamivir in human plasma using SPE in the 96-well plate format and LC coupled to positive MS/MS has been developed and validated according to US FDA guidelines. The method uses 50 microl of plasma and covers a large working range from 1-50, 000 ng/ml with a LOD of 0.50 ng/ml.

CONCLUSION

this new LC-MS/MS assay is more sensitive than previous methods despite using a small plasma volume sample. It is particularly suitable for clinical studies on both parenteral and inhaled zanamivir.

背景

胃肠外给予扎那米韦是一种有前景的治疗重症流感的药物。然而，传统上在生物基质中对这种极性药物进行定量分析一直很困难，并且所开发的方法相对不够灵敏。

结果

已根据美国食品药品监督管理局（US FDA）的指导原则开发并验证了一种高通量生物分析方法，该方法采用96孔板形式的固相萃取（SPE）和液相色谱（LC）联用正离子质谱/质谱（MS/MS）来分析人血浆中的扎那米韦。该方法使用50微升血浆，工作范围广，为1 - 50,000纳克/毫升，检测限为0.50纳克/毫升。