Determination of the Content of Trepibutone and Related Compounds by HPLC

OBJECTIVE To establish an HPLC method for the determination of the content of trpibutone and related substances. METHODS The HPLC system consisted of Thermo C₁₈ column(250 mm×4.6 mm, 5 μm) was used, methanol-buffer(0.01 mol·L^-1 ammonium acetate, adjusted pH to 3.0 by phosphoric acid) (40∶60) was adopted as mobile phase with UV detection at 271 nm. The flow rate was 1.0 mL^-1, column temperature was 35 ℃, injection volume was 10 μL. RESULTS The linear range was 0.100 5-1.005 2 mg·mL^-1. The mean recovery was 100.5%(RSD=0.5%). Trepibutone and related substances were separated well. The limit of quantification was 0.000 1 ng, the limit of detection was 0.000 03 ng. The sample solution was stable within 8 h(RSD=0, 6%). CONCLUSION This method is simple, sensitive and accurate.