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目的:建立高效液相色谱法测定利伐沙班中对映异构体含量。方法:色谱柱为Chiralpak IA(250 mm×4.6 mm,5μm),流动相为100%甲醇,流速为1.0 ml·min-1,检测波长为250 nm,柱温为40℃。结果:利伐沙班与其对映异构体之间的分离度大于2.0,两者在0.5~1000.00 μg·ml-1范围内呈良好的线性关系,r均为0.9999,对映异构体检测限为0.17 ng,平均加样回收率为102.9%,RSD为1.54%(n=6)。结论:该方法准确、快速,可用于利伐沙班中对映异构体的含量测定。
Objective: To establish an HPLC method for the determination of enantiomers in rivaroxaban. Methods: The chromatographic column was Chiralpak IA (250 mm × 4.6 mm, 5 μm). The mobile phase consisted of 100% methanol and the flow rate was 1.0 ml · min-1. The detection wavelength was 250 nm and the column temperature was 40 ℃. Results: The separation of rivaroxaban and its enantiomers was more than 2.0. The linear relationship between rivaroxaban and its enantiomer showed good linearity in the range of 0.5-1000.00 μg · ml-1 (r = 0.9999). Enantiomer detection The limit was 0.17 ng with an average recovery of 102.9% and a RSD of 1.54% (n = 6). Conclusion: The method is accurate and rapid and can be used for the determination of enantiomers in rivaroxaban.