HPLC法测定富马酸喹硫平缓释片的含量  

Content Determination of Quetiapine in Quetiapine Fumarate Extended-release Tablets by HPLC

作　　者：刘艳妮[1] 蒋海松[2] 高丽[2] 丁黎[1] 

机构地区：[1]中国药科大学药物分析教研室,南京210009 [2]北京科信必成医药科技发展有限公司哈尔滨分公司,哈尔滨150008

出　　处：《黑龙江医药》2012年第1期2-4,共3页Heilongjiang Medicine journal

摘　　要：目的:建立HPLC法测定富马酸喹硫平缓释片的含量。方法:采用C18(4.6mm×250mm,5μm)色谱柱,以甲醇-水-三乙胺(600:400:4)(磷酸调节pH值为6.8)为流动相,检测波长为289nm,流速为1.0mL/min。结果:喹硫平在80.33μg/mL～281.17μg/mL范围内线性关系良好,回归方程:y=393528x-523868,相关系数γ=0.9999,平均回收率是100.2%(RSD=0.28%)。方法的精密度、重复性、回收率、稳定性均较为理想。结论:本方法简单灵敏,重复性好,可作为富马酸喹硫平缓释片的含量测定方法。Objective：An HPLC method has been established for the content determination of quetiapine in Quetiapine Fumarate Extended release Tablets. Methods：The chromatographic system consists of C ls column （4. 6mm x 250mm ,5 p.m）, mobile phase of a mixture of methol Water monobasci triethylamine （ 60 ： 40： 0. 4） （ adjusted to pH 6. 8with phosphoric acid） as the mobile phase. Detection wavelengths is 289nm. The flow rate is 1.0mL/min. Results：The linear range of Quetiap ine was within 80. 33p.g/mL - 281.17trg/mL,the equation was y = 393528x - 523868, correlation coefficient was 0. 9999 and the average recovery of Quetiapine was 100. 2% ,RSD was 0. 28%. Conclusion：The method is simple,feasible,and re producible. It can be used to determine the content of quetiapine in Quetiapine fumarate extended release tablets.

关 键 词：富马酸喹硫平 缓释片 含量测定 HPLC 

分 类 号：R927.2[医药卫生—药学]