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A rapid LC-MS/MS quantification of peramivir using a simple and inexpensive sample precipitation: application to PK
Zhan-Zhang Wang1, Ming Zhang, De-Wei Shang
1Clinical Pharmacy of Guangzhou Brain Hospital, Guangzhou Medical University, 36 MingXin Road, Guangzhou 510370, China.
Aim:
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.
Conclusion:
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.
Insights
A new liquid chromatography-tandem mass spectrometry (LC-MS/MS) method enables accurate quantification of peramivir in plasma. This validated assay supports clinical studies for the influenza antiviral drug.
Area of Science:
- Pharmacology
- Analytical Chemistry
- Infectious Diseases
Background:
- Peramivir is a selective neuraminidase inhibitor targeting influenza virus.
- Accurate quantification of antiviral drugs in biological matrices is crucial for pharmacokinetic studies.
Purpose of the Study:
- To develop and validate a sensitive and robust LC-MS/MS method for quantifying peramivir in human plasma.
- To support clinical pharmacokinetic investigations of peramivir.
Main Methods:
- Simple precipitation extraction followed by LC-MS/MS analysis.
- Optimization of mobile phase composition (ammonium formate and formic acid) to minimize matrix effects.
- Validation according to US FDA guidelines, assessing linearity, sensitivity, and other parameters.
Main Results:
- The method demonstrated high sensitivity and robustness for peramivir quantification.
- A linear concentration range from 5 to 10,000 ng/ml was established using 100 µl of plasma.
- Validation parameters met US FDA regulatory expectations, confirming method reliability.
Conclusions:
- The developed HPLC-MS/MS method is suitable for supporting clinical pharmacokinetic studies of peramivir.
- The presented analytical strategy may be applicable to other amphiphilic drugs.
- This quantification method aids in understanding peramivir's behavior in vivo.
