Objective: A method for determining formic acid content of febuxostat residual solvent by pre-column derivatization-gas chromatog. was established.Methods: DB-WAX UI (30 m×0.25 mm×0.5 μm) column was used with hydrogen flame ion detector (FID).The detector temperature was 230°C.Results: The formic acid resolution was good, the linear relationship was good in the concentration range of 2.5∼500.0 μg/mL (r=0.9999), the limit of quantification was 2.5 μg/mL, the detection limit was 0.7 μg/mL, the average recovery rate was 97.8%, the RSD was 1.9%, and the test solution was stable.Organic solvent formic acid was detected in 3 batches of samples of febuxostat API, and the test results all met the limit of formic acid (not exceeding 0.5%).Conclusion: This method is simple to operate, accurate and reliable, and has high sensitivity, which is suitable for the anal. and detection of formic acid residual solvent in febuxostat APIs.