HPLC-RID法测定托吡酯含量及主要有关物质

目的: 建立托吡酯含量测定及有关物质检查的方法。 方法: 采用Phenomenex Luna C₈柱(250 mm×4.6 mm,5 μm),柱温35 ℃,光学元件温度:35 ℃;流动相为乙腈-0.01 mol·L^-1醋酸铵溶液(用醋酸调节pH为4.2)(1∶ 2),流速为1.0 mL·min^-1,示差折光检测器。 结果: 高效液相色谱法测定的线性范围为:托吡酯5~15 mg·mL^-1,相关系数r=0.9999;杂质10~90 μg·mL^-1,相关系数r=0.9999;日内精密度:托吡酯RSD为0.3%(n=6),杂质RSD为1.0%(n=6);日间精密度:托吡酯RSD为1.0%(n=5),杂质RSD为1.0%(n=5)。 结论: 方法简单,灵敏度较好,可用于托吡酯的含量检测和主要杂质的研究。

Objective: To establish an HPLC-RID method for the determination of topiramate and its related substance. Method: The separation was performed on a Phenomenex Luna C₈ column (250 mm×4.6 mm,5 μm),and the column temperature was 35 ℃.The mobile phase consist of acetonitrile-0.01 mol·L^-1 ammonium acetate solution (adjusted to pH 4.2 with acetic acid) (1∶ 2),the flow rate was 1.0 mL·min^-1,using the differential refractive index detector. Results: The calibration curves of topiramate were linear between 5-15 mg·mL^-1 (r=0.9999),and the calibration curves of its main related substance were linear between 10-90 μg·mL^-1 (r=0.9999).Intra-day and inter-day RSDs were 0.3%(n=6),1.0%(n=6) and 1.0%(n=5),1.0%(n=5). Conclusion: The method was found to be simple,sensitive and can be applied to determine the major impurity of topiramate.