Method development and validation for the estimation of gedatolisib in mouse plasma by tandem mass spectrometry and its application to pharmacokinetics studies

column using an isocratic mobile phase (10 mm ammonium formate and acetonitrile; 30:70% v/v, both supplemented with 0.1% formic acid) delivered at a flow rate of 0.7 ml/min. The total run time was 2.0 min, and gedatolisib and idelalisib were eluted at 0.80 and 0.95 min, respectively. Gedatolisib was monitored at m/z 616.40 → 488.20 and idelalisib at 416.05 → 176.10. All the required parameters for the method validation were performed as per US Food and Drug Administration guidelines, and the results were within the acceptance criteria. The method was accurate and proved to be precise at a linearity range of 1.33-2667 ng/ml. The accuracy for gedatolisib in mouse plasma was in the ranges 0.99-1.06% (intra-day) and 0.96-1.04% (inter-day). Gedatolisib appeared to be stable in a series of stability conditions. Gedatolisib showed a good intravenous profile when administered through a solution formulation.