Wang Zhan-Zhang, Zhang Ming, Shang De-Wei, Ni Xiao-Jia, Hu Jin-Qing, Qiu Chang, Wen Yu-Guan
Clinical Pharmacy of Guangzhou Brain Hospital, Guangzhou Medical University, 36 MingXin Road, Guangzhou 510370, China.
Bioanalysis. 2015;7(3):319-32. doi: 10.4155/bio.14.248.
Peramivir is a newly approved selective neuraminidase inhibitor designed to inhibit influenza virus infection.
METHODOLOGY/RESULTS: We report a robust and sensitive method utilizing simple precipitation extraction with LC-MS/MS for the high-throughput quantification. Addition of 0.06 M of ammonium formate and 0.1% formic acid in mobile phase could help reduce the matrix effect. This method uses 100 µl of plasma and covers a linear concentration range from 5 to 10,000 ng/ml. Other validation parameters are also evaluated and meet regulatory expectations by US FDA guidelines.
The developed HPLC-MS/MS method has been successfully applied to support a clinical pharmacokinetic study. The strategy presented here can be applied elsewhere and may be useful for other amphiphilic drugs.
帕拉米韦是一种新批准的选择性神经氨酸酶抑制剂，旨在抑制流感病毒感染。
方法/结果：我们报告了一种稳健且灵敏的方法，该方法利用简单的沉淀萃取结合液相色谱-串联质谱法进行高通量定量分析。在流动相中添加0.06 M的甲酸铵和0.1%的甲酸有助于降低基质效应。该方法使用100 μl血浆，线性浓度范围为5至10,000 ng/ml。还评估了其他验证参数，并且这些参数符合美国食品药品监督管理局（US FDA）指南的监管要求。
所开发的高效液相色谱-串联质谱法已成功应用于支持一项临床药代动力学研究。此处介绍的策略可应用于其他地方，并且可能对其他两亲性药物有用。
