A method for determining isomers of tenofovir alafenamide

Abstract

The present invention provides a method for determining the isomers of tenofovir alafenamide by high performance liquid chromatography, wherein the high performance liquid chromatography conditions are: using chiral C 18 The reversed-phase silica gel column has a detection wavelength of 260 nm, a flow rate of 0.1-1.0 ml / min, a column temperature of 20-40 ° C, an injection volume of 5-50 μl, and a mobile phase consisting of phase A and phase B; wherein the phase A is an organic solvent, the phase B is an aqueous solution at pH 6-9, and the volume ratio of the phase A to the phase B is 10:90-50:50. The present invention adopts a chiral C 18 The reversed-phase silica gel chromatography column is used for high performance liquid chromatography detection of the difficult-to-separate corresponding isomeric impurities of tenofovir alafenamide. It has low equipment requirements, high versatility, low cost, and is suitable for large-scale industrial detection. At the same time, by optimizing the elution conditions, the corresponding isomeric impurity 1 and other diastereoisomers can be detected simultaneously, which simplifies the operation steps, reduces the detection frequency, saves detection time and cost, and greatly saves the cost of industrial quality control.