摘要
目的:建立测定利伐沙班原料药的有关物质的HPLC方法。方法:采用Waters XBridge RP18(250*4.6 mm,5μm)色谱柱,采用梯度洗脱方式进行洗脱;0.1 mol/L的磷酸二氢钠-乙腈(95∶5)为流动相A,乙腈为流动相B,检测波长240 nm,柱温30℃,流速1.0 mL/min。结果:利伐沙班及其已知杂质(杂质A、杂质B、杂质C、杂质D、杂质E、杂质F)在浓度0.15~3.0μg/m L范围内线性关系良好。平均回收率分别为94.7%、95.8%、100.6%、96.4%、96.9%。结论:该方法专属性强、灵敏度高、操作简便,适用于利伐沙班原料药有关物质的测定。
Objective： To establish a HPLC method for determination of rivaroxaban related substances. Methods：The analysis was performed on a Waters XBridge RP 18 （250x4.6 mm, 5μm）. The mobile phase was composed of Acetonitrile and 0. IM phosphate buffer solution with the volume ratio of 5 ： 95. The flow rate of mobile phase and the detection wavelength and the column temperature were 1.0 mL/min and 240 nm and 30 ℃, respectively. Results： The chromatographic peak area and concentration Hydrochlorothiazide showed a good linear relationship at the range of 0.15-3.0 μg/mL. The average recovery of Hydrochlorothiazide was 94.7 %, 95.8 %, 100.6 %, 96.4%, 96.9 %. Conclusion：The method is specific, sensitive and simple operation. It can be used for determination of rivaroxaban related substances.
出处
《广东化工》
CAS
2017年第24期94-95,共2页
Guangdong Chemical Industry
