目的:建立高效液相色谱(HPLC)法测定氟哌噻吨美利曲辛片有效成分的含量并控制杂质。方法:色谱柱为C18(150 mm×4.6 mm,5μm);流动相为甲醇-0.2%磷酸(含0.1%三乙胺)(65∶35);流速1.0 mL/min,柱温30℃,检测波长257 nm,进样量20μL。结果:美利曲辛测得含量为标示量的98.89%,线性浓度范围20~240μg/mL,低、中、高浓度供试品的平均回收率分别为102.8%、99.5%、99.5%;氟哌噻吨测得含量为标示量的96.17%,线性浓度范围10~100μg/mL,低、中、高浓度供试品的平均回收率分别为100.1%、101.8%、100.2%。杂质总量与美利曲辛含量的百分比<1.0%。结论:该方法灵敏、准确、专属性强,可用于氟哌噻吨美利曲辛片的质量控制。 OBJECTIVE: To establish a HPLC method for the determination of the active ingredient in flupenthixol and melitracen tablets and to control the impurities. Methods: The column was C18 (150 mm × 4.6 mm, 5 μm). The mobile phase was methanol-0.2% phosphoric acid (containing 0.1% triethylamine) (65:35). The flow rate was 1.0 mL / Wavelength 257 nm, injection volume 20μL. Results: The concentrations of metytamycin measured were 98.89% of the labeled amount and the linear range was 20 ~ 240μg / mL. The average recoveries of low, medium and high concentrations were 102.8%, 99.5% and 99.5% The concentration of pendimethoxine was 96.17% of the labeled amount, and the linear range of concentration was 10 ~ 100μg / mL. The average recoveries of low, middle and high concentration of the samples were 100.1%, 101.8% and 100.2% respectively. The total amount of impurities and the percentage of the content of the United States of Victoria <1.0%. Conclusion: The method is sensitive, accurate and specific and can be used for the quality control of flupentixol and melitracen tablets.