Objective:To establish an HPLC method for the determination of flibanserin and its related substances. Methods: A Phenomenex Luna C18 column(150 mm × 4. 60 mm, 5 μm) was used, the mobile phase consisted of 0. 02 mol·L-1 potassium di-hydrogen phosphate solution (pH was adjusted to 6. 0 by sodium hydroxide)-methanol and acetonitrile (4 :1), the flow rate was 1. 0 ml·min-1 , the column temperature was 30℃, the detection wavelength was 260 nm, and the injection volume was 10 μl. Results:Flibanserin and all the related compounds could be well separated. The linear range was 20-500 μg·ml-1(r=0. 9998), the average recovery was 100. 0%(RSD=0. 90%,n=9). The content of the main component in 4 batches of samples was 99. 6%, 99. 8%, 100. 4% and 99. 4%, respectively. The single impurity limit was set at 0. 1% and the limit of total impurities was set at 0. 5%. Con-clusion:The method is specific and accurate, which can be applied in the determination of content and related substances of fliban-serin.%目的:建立高效液相色谱法测定氟班色林原料药的含量及有关物质.方法:采用Phenomenex Luna C18色谱柱(150 mm×4.6 mm,5μm),流动相:0.02 mol·L-1磷酸二氢钾(氢氧化钠调pH至6.0)-甲醇:乙腈(4:1),流速:1.0 ml·min-1,柱温:30℃,检测波长:260 nm,进样量:10μl.结果:氟班色林与各有关物质均能良好地分离,氟班色林的质量浓度在20~500μg·ml-1内线性关系良好(r=0.9998),平均回收率为100.0%(RSD=0.90%,n=9),4批样品中主成分含量分别为99.6%、99.8%、100.4%及99.4%;单个杂质限量定为0.1%,杂质总量为0.5%.结论:本法专属性好,准确性高,可用于氟班色林原料药含量测定和有关物质检测.
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