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目的采用HPLC法测定非那雄胺片中有关物质的含量。方法色谱柱为Kromasil Eternity 5-C18柱(250 mm×4.6mm,5μm),流动相为0.01 mol·L-1磷酸二氢钾溶液-乙腈(64∶36),流速1.0 m L·min-1,柱温45℃,检测波长210 nm。结果非那雄胺、杂质A、B、C的线性范围为1.5~4.5μg·m L-1;杂质A、C和杂质总量的平均含量分别为0.18%、0.12%、0.37%,RSD分别为0.18%、0.12%、0.65%,均未检出杂质B;杂质A、B、C的相对保留时间分别为0.9、1.1、1.2,校正因子分别为2.7、1.0、0.7。结论所用方法简便、准确,适用于非那雄胺片中有关物质的检查。
Objective To determine the content of related substances in finasteride tablets by HPLC. METHODS The column was Kromasil Eternity 5-C18 (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of 0.01 mol·L-1 potassium dihydrogen phosphate solution-acetonitrile (64:36) and the flow rate was 1.0 m L · min-1 , Column temperature 45 ℃, detection wavelength 210 nm. Results Finasteride had a linear range of 1.5-4.5 μg · mL -1 for impurities A, B and C. The average contents of impurities A, C and impurities were 0.18%, 0.12% and 0.37%, respectively 0.18%, 0.12% and 0.65%, respectively, and no impurity B was detected. The relative retention times of impurities A, B and C were 0.9, 1.1 and 1.2, respectively, and the correction factors were 2.7, 1.0 and 0.7 respectively. Conclusion The method used is simple and accurate and suitable for the examination of the related substances in finasteride tablets.