DEVELOPMENT AND VALIDATION FOR HIGH-PERFORMANCE MASS SPECTROMETRY METHOD FOR DETERMINATION OF BALOXAVIR MARBOXIL IN BIOLOGICAL MATRICESAbstract
The validated protein precipitation method was applied for the estimation of Baloxavir marboxil in human plasma with Oseltamivir as an internal standard (ISTD) by using HPLC-ESI-MS/MS. The chromatographic separation was achieved with 0.1% formic acid in combination with methanol (25:75 v/v) using the C18 column Ascentis Express (50 mm × 4.6 mm, 2.7 µm). The total analysis time was 3 min and the flow rate was set to 0.6 ml/min. The mass transitions of Baloxavir marboxil and Oseltamivir obtained were m/z 572.6®250.3 and 313.2®269.1. The standard curve shows a correlation coefficient (r2) greater than 0.9983 with a range of 5.00-10000.00 pg/ml using the linear regression model.