UPLC法测定氢溴酸加兰他敏片的含量

Determination of Assay in Galantamine Hydrobromide tablets by UPLC

目的建立氢溴酸加兰他敏片的含量的UPLC方法。方法采用Waters ACQUITY UPLC BEH C18色谱柱(2.1 mm×50 mm,1.7μm),磷酸氢二钠缓冲液-甲醇(95∶5)和乙腈-甲醇(95∶5)为流动相,梯度洗脱,流速为0.6 mL/min,检测波长为230 nm,柱温35℃。结果氢溴酸加兰他敏对照品溶液线性范围为:0.1~150μg/mL,r=0.9999(n=9);回收率为98.5%~100.2%,RSD为0.6%(n=6)。结论 UPLC法简便、灵敏、准确、重复性好,可用于氢溴酸加兰他敏片的质量控制。

Objective To establish a UPLC method for determination of galantamine hydrobromide tablets. Methods Use Waters ACQUITY UPLC BEH C18 column （2.1 mm×50 mm, 1.7 μm）, gradient elution with the mobile phase consisted of di-sodium hydrogen phosphate buffer solution-methanol （95 ： 5） and acetonitrile-methanol （95 ： 5）, the flow rate was 0.6 mL/min, detection wavelength at 230 nm, the column temperature was 35 ℃ o Results The linear range of the method was 0.1-150 μg/mL, r=0.9999 （n=9）, the recovery was 98.5%-100.2%, with RSD of 0.6% （n=6）. Conclusion The UPLC method is simple, sensitive, and accurate and can be used for the determination of galantamine hydrobromide tablets.