RP-HPLC法测定富马酸喹硫平分散片主药的含量

Determination of Content of Quetiapine Fumarate in Quetiapine Fumarate Dispersible Tablets by RP-HPLC

目的建立富马酸喹硫平分散片含量的测定方法。方法以C18为色谱柱,流动相为甲醇-0.2%的三乙胺水溶液(70∶30),检测波长为254 nm,流速为1 mL/min,柱温为30℃,进样量是10μL。结果富马酸喹硫平在100.32～601.92μg/mL(r=0.999 7)浓度范围内与峰面积有良好的线性关系,平均回收率是99.8%,RSD是0.7%。结论本方法简便、准确、专属性强、回收率高,可用于该制剂的质量控制。

Objective To establish a method for the determination of the content of quetiapine fumarate in quetiapine fumarate dispersible tablets by RP-HPLC. Methods HPLC was performed on a C18 column using methanol-0.2% of trithylamine solution （70： 30） as the mobile phase at a flow rate of 1 mL/min. The detection wavelength was at 254 nm. The column temperature was 30 ℃ and the sample size was 10μL. Results The linear range of quetiapine fumarate was 100.32 - 601.92 μg/mL （ r = 0. 999 7 ）, and the average recovery was 99.8%, RSD was 0.7%. Conclusion The method is simple, accurate, and specific, and can be used for the quality control of quetiapine fumarate dispersible tablets.