Establishment of a Dissolution Method of PI3Kδ Selective Inhibitor
The main purpose of this study is to establish a dissolution method for XT01 tablets that can distinguish from different for-mulations and process parameters.The HPLC method adopted a Sunfire C18 column(4.6 mm × 50 mm,3.5 μm)and a mobile phase containing of a 0.05％aqueous solution of trifluoroacetic acid(v/v)and a 0.05％solution of trifluoroacetic acid in acetoni-trile(v/v)(75∶25)at flow rate of 1.0 mL/min.The detection wavelength was set at 246 nm,the column temperature was main-tained at 30 ℃,and the injection volume was 15 μL.The discriminative dissolution method was developed by evaluation of the effects of different dissolution media,surfactants,and stirring speed on the dissolution behavior of XT01 tablets,and the method was validated in items of specificity,linearity,accuracy,recovery,solution stability,and filter bias.The paddle method was used to deter-mine XT01 dissolution at 75 r/min and 37 ℃,with a pH 6.8 phosphate solution containing 0.20％sodium dodecyl sulfate as the dissolution medium.The method validation results met the requirements,and XT01 exhibited good linearity in the range of 4.4 to 26.8 µg/mL.The dissolution method is suitable for testing the dissolution of XT01 tablets and can discriminate the dissolution behaviors of tablets produced using different formulations and process parameters.
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