反相高效液相色谱法测定利伐沙班原料药的含量

Reversed Phase High-performance Liquid Chromatography in Measuring the Content of Rivastopharan Raw Drug

目的建立反相高效液相色谱法测定利伐沙班的含量。方法色谱柱为ZORBAX SB-C18(4.6×150 mm,5 um);以乙腈-水(40:60)为流动相;流速1.0 m L/min,检测波长为250 nm。结果利伐沙班在浓度为10.15~30.45μg/m L范围内与峰面积的线性关系良好(r=0.999 9,n=5),平均回收率为99.64%(RSD为0.16%,n=9)。结论方法准确度、精密度良好,适用于利伐沙班的含量测定。

Objective To establish the reversed phase high-performance liquid chromatography in measuring the content of rivastopharan raw drug. Methods Chromatographic column was ZORBAX SB-C18（4.6×150 mm,5 um）, and acetonitrile/water（40：60）was the mobile phase and the velocity was 1.0 m L/min,and the test wavelength was 250 nm. Results The concentration of rivastopharan had a good liner correlation with peak area in 10.15~0.45 μg/m L,（r=0.999 9,n=5）, and the average recycle rate was 99.64%（RSD,0.16%,n=9）. Conclusion The accuracy of the method is good with good precision, which is suitable for the content measurement of rivastopharan.