加校正因子的主成分自身对照法同时测定非那雄胺片中2个杂质

Determination of the related substances in finasteride tablets by the main component self-control method with correction factor

目的:建立加校正因子的主成分自身对照法测定非那雄胺片中有关物质的含量。方法:CAPCELL PAK C_(18)色谱柱(4. 6 mm×250 mm,5μm),流动相乙腈-水(45∶55),流速1. 0 mL·min^(-1),检测波长210 nm,进样量20μL,柱温30℃。测定非那雄胺与杂质Ⅰ、Ⅱ的标准曲线方程,以斜率计算杂质相对于非那雄胺的校正因子,用相对保留时间确定各杂质的位置。结果:非那雄胺杂质Ⅰ、Ⅱ的相对保留时间分别为0. 85与1. 30,相对校正因子分别为2. 40与0. 69。结论:本方法可用于非那雄胺片中有关物质的定性及定量分析,采用加校正因子的主成分自身对照法可以更准确的反映其有关物质的含量。

Objective： To establish a main component self-control method with correction factor for the determination of related substances in finasteride tablets. Methods： The test was performed on a CAPCELL PAK C18 column （4. 6mm×250 mm, 5μm） under the elution of acetonitrile-water （45： 55）. The flow rate was 1.0 mL·min^-1 the detection wavelength was 210 nm, and the column temperature was set as 30℃. The injection volume was 20 of impurity I , II were 0. 85 and 1.30, respectively. The relative correction factor values of impurities I , II were 2.40 and 0. 69, respectively. Conclusion： The established method can be used for the qualitative and quantitative analysis of the related substances in finasteride tablets, and the main component self-control method with correction factor can determine the contents of impurities more accurately.