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目的:建立二甲氨基阿格拉宾盐酸盐的含量测定方法。方法:色谱柱为氨基柱(250mm×4.6mm,5μm),以乙腈-0.01mol·L~(-1)磷酸铵(用磷酸调节pH至6.5)(60:40)为流动相,流速为1.0ml·min~(-1),检测波长为210nm,柱温30℃,进样量20μl。结果:二甲氨基阿格拉宾盐酸盐与阿格拉宾及其他杂质之间能够达到很好分离;二甲氨基阿格拉宾盐酸盐在1.0~6.0mg·ml~(-1)浓度范围內线性关系良好(r=0.9999),平均加样回收率为99.07%,RSD为0.76%(n=9)。结论:该法测定二甲氨基阿格拉宾盐酸盐含量,简便、准确、重复性好。
Objective: To establish a method for the determination of dimethylaminogalactam hydrochloride. METHODS: The column was an amino column (250 mm × 4.6 mm, 5 μm). The mobile phase was acetonitrile-0.01 mol·L -1 ammonium phosphate (adjusted to pH 6.5 with phosphoric acid) (60:40) at a flow rate of 1.0 ml · min ~ (-1), the detection wavelength was 210nm, the column temperature was 30 ℃ and the injection volume was 20μl. Results: Dimethylaminoacelazabam hydrochloride was well separated from agalabeline and other impurities. Dimethylaminoacelazabam hydrochloride was in the range of 1.0-6.0mg · ml -1 The linearity was good (r = 0.9999). The average recovery was 99.07% and the RSD was 0.76% (n = 9). Conclusion: The method for the determination of dimethylaminogalactam hydrochloride is simple, accurate and reproducible.