反相HPLC法测定重酒石酸卡巴拉汀胶囊的含量及有关物质

目的: 建立HPLC法测定重酒石酸卡巴拉汀胶囊的含量及有关物质。 方法: 采用Hypersil BDS C₁₈色谱柱(250 mm×4.6 mm,5 μm),以甲醇-0.05 mol·L^-1磷酸氢二钠溶液(58∶ 42,用磷酸调节 pH至 8.45)为流动相;流速为 1.0 mL·min^-1;检测波长为 214 nm;柱温:40 ℃。 结果: 在所选色谱条件下,主药与有关物质能较好分离,重酒石酸卡巴拉汀在23.6~447.1 μg·mL^-1范围内,线性关系良好(r=0.9997);平均回收率为99.3%(RSD= 0.35% ,n=9);检测限为0.3 ng;样品中有关物质检查符合质量要求。 结论: 该方法简便灵敏,专属性强,精密度高,可用于重酒石酸卡巴拉汀胶囊的质量控制。

Objective: To establish an RP-HPLC method for the determination of rivastigmine capsules and its related substances. Methods: The separation was performed on a Hypersil BDS C₁₈(250 mm×4.6 mm,5 μm) column,with the mobile phase consisting of methanol-0.05 mol·L^-1 sodium hydrogen phosphate solution(58∶ 42,adjusted to pH 8.45 with phosphate acid); The flow rate was 1.0 mL· min^-1,the detection wavelength at 214 nm,the column temperature was 40 ℃. Results: Rivastigmine and its related substances were completely separated by the method with a good linear range of 23.6-447.1 μg· mL^-1(r=0.9997) ; the average recovery (n=9) was 99.3%; the limit of the detection was 0.3 ng.The related substances met the quality requirements in samples. Conclusion: The method is simple,sensitive,accurate and specific.It can be used for quality control of rivastigmine capsules.