摘要
目的建立HPLC法测定利伐沙班原料药的有关物质。方法采用Purospher Star RP-18endcapped(55mm×4.0mm,3μm)色谱柱;10mmol·L-1磷酸为流动相A,乙腈为流动相B,梯度洗脱;进样量为5μL;检测波长为250nm;流速为1.0mL·min-1;柱温为45℃。结果利伐沙班及各杂质能得到良好的分离,3批样品中单一杂质的含量质量分数均小于0.1%。结论该方法可用于利伐沙班原料药中有关物质的检测。
Objective To develop an HPLC method for determination of rivaroxaban related substances. Methods The chromatographic column was Purospher Star RP- 18endcapped（55 nun × 4.0 mm,3 m）. The mobile phase A was 10 mmol·L-1 phosphate acid and acetonitrile was the mobile phase B. A gradient elution was used at a flow rate of 1.0 mL· min-1. The injection volume was 5 μL and the detection wave- length was at 250 nm. The column temperature was 45 ℃. Results The separation of rivaroxaban and its re- lated compounds are good. The impurities have been found with levels below 0.1% （w） in the drug sub- stance. Conclusions The method can be used for the determination of rivaroxaban related substances in rivaroxaban materials.
出处
《沈阳药科大学学报》
CAS
CSCD
北大核心
2015年第8期627-632,共6页
Journal of Shenyang Pharmaceutical University
