HPLC法测定琥珀八氢氨吖啶原料药的含量

HPLC determination of octahydroaminoacridine succinate

目的:建立反相高效液相色谱法测定创新药琥珀八氢氨吖啶原料药的含量。方法:采用YMC-Pack Pro C_(18)柱(5μm,250 mm×4.6 mm),流动相:0.05 moL·L^(-1)三乙胺(甲酸调节pH 3.0)-乙腈(87:13);流速:1.0 mL·min^(-1);检测波长:268nn;柱温:30℃;进样量20μL;外标法定量。结果:琥珀八氢氨吖啶峰与相邻杂质峰能完全分离,琥珀八氢氨吖啶在0.2～2.0μg·mL^(-1)浓度范围内呈良好的线性关系(r=0.9999),回归方程为Y=3.0×10~5X+1.9×10~3。回收率、精密度、耐用性等实验均符合测定要求,最低定量限为5 ng。结论:该法简便、准确,专属性好,可以用于琥珀八氢氨吖啶的含量测定。

Objective ：To establish an RP - HPLC method for determination of octabydroaminoacridine succinate. Methods：Octahydroaminoacridine succinate was chromatographed on Shimadzu HPLC with a C18 （5μm,250 mm × 4. 6 mm） column, and detected at 268 nm. The mobile phase was 0. 05 mol · L ^-1 triethylamine （ adjusted to pH 3.0 with formic acid） -acetonitrile（87： 13） at flow rate of 1.0 mL ·min^-1 with the column temperature at 30 ℃ ,the injection volume was 20 μL. Results： A good linear relationship was obtained, concentration of octahydroaminoacridine succinate over the range of 0. 2 to 2.0 μg · mL^-1, The linear equation was Y = 3.0 × 10^5X ＋ 1.9 × 10^3, r = 0. 9999. The RSD of within - day was less than 2%. Recovery, precisiong, durability of the method were good. The limit of quantitation was 5 ng. Conclusion ： The method is simple, accurate and is suitable for the determination of octahydroaminoacridine succinate.