LC-ESI-MS/MS Method for the Fosamprenavir Quantification Bioanalytical Method Development and Validation for the Quantification Fosamprenavir in Human Plasma by LC-ESI-MS/MS

Abstract

Objectives: The main goal of the current research was to develop a bioanalytical technique for the quantification of fosamprenavir in plasma by LC-ESI-MS/MS.Materials and Methods: Chromatographic elution was attained thru a Zorbax (3.5 μm; 50×4.6 mm) analytical C18-column with isocratic system by methanol, 0.1%v/v formic acid and acetonitrile in the ratio of 60:10:30 V/V as mobile phase with flowrate of 0.70 ml/ min. Liquid-liquid extraction was executed for the drug separation with an ethyl acetate solvent. Parent and product ions were monitored at m/z 586.19 /57.0 for Fosamprenavir and 590.0/61.0 for Fosamprenavir-D4 on MRM.Results: Linearity plot of fosamprenavir was rectilinear over the concentration of 4.0- 1600.0 ng/ml with correlation coefficient (r2) value of more than 0.99. The developed procedure has fine recovery with percentage recovery findings of HQC, MQC and LQC standards were present between 89.65% to 95.61%. The % RSD findings were < 6.30% for intra-day and inter-day accuracy and precision.Conclusion: Fosamprenavir has more stability for longer time when subjected for different stability environments and the technique was effectively relevant to routine analysis of fosamprenavir in biological matrix.

Keywords: Fosamprenavir; Protease inhibitor; LC-MS/MS; FDA guidelines; Acuuracy