【摘要】 目的:建立RP-HPLC法测定厄贝沙坦的含量及有关物质。方法:采用ShimadzuVP-ODS(150mm×4.6mm,5μm)色谱柱,乙腈-0.02mol/L磷酸二氢钾溶液(用磷酸调节pH=2.6()40:60)为流动相,检测波长245nm,流速1.0mL/min。结果:厄贝沙坦与各杂质及降解产物分离良好,在4-240μg/mL范围内线性关系良好(r=0.9999),平均回收率99.73%,RSD为0.77%,最低检出限0.6ng。结论:该方法简便、快速、准确,可用于厄贝沙坦含量及有关物质的测定。更多还原

【Abstract】 Objective: To establish an RP-HPLC method for determination of irbesartan and its related substances. Methods: The separation was performed on a Shimadzu VP-ODS column (150mm×4.6mm, 5μm) with detective wavelength at 245nm. The mobile phase consisted of acetonitrile-0.02mol/L potassium dihydrogen phosphate(adjusted to pH 2.6 with phosphoric acid) (40:60) with flow rate of 1.0mL/min. Results: Irbesartan was separated with the impurities and degraded substances efficiently. The calibration curve was linear in the range of 4-240μg/mL (r=0.9999). The average recovery was 99.73% with RSD of 0.77%. The limit of detection was 0.6ng. Conclusion: The method was proved to be simple, rapid and accurate. It is suitable for determination of irbesartan and its related substances.更多还原