HPLC法测定富马酸喹硫平缓释片中喹硫平氮氧化物及其它有关物质  

Determination of Quetiapine N-Oxide and other Related Components in Quetiapine Fumarate Extended-release Tablets by HPLC

作　　者：刘艳妮[1] 高丽[2] 蒋海松[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3期355-358,共4页Heilongjiang Medicine journal

摘　　要：目的:建立HPLC法测定富马酸喹硫平缓释片中有关物质的测定方法。方法:采用Thermo C8(4.6mm×250mm,5μm)色谱柱;以乙腈-甲醇-0.02mol·L-1磷酸氢二铵溶液(6:49:45)为流动相,检测波长为230nm,流速为1.0mL·min-1。结果:该法可以检测到6个杂质,各杂质峰与喹硫平峰的分离度良好。在0.0446～2.676μg·mL-1范围内,喹硫平氮氧化物峰面积和浓度呈良好的线性关系,回归方程:y=83826x-1135.9,相关系数γ=0.9999,喹硫平氮氧化物的平均回收率是101.0%(RSD=0.04%)。结论:本方法简便,准确,重现性好,能够用于富马酸喹硫平缓释片的质量控制。Objective：An HPLC method has been established for the determination of the related components in Quetiap- ine Fumarate Extended - release Tablets. Methods： An HPLC method was adopted with Thenno C8 column （ 4. 6ram x 2.50mm,Sp,m）. The mobile phase consisted of a mixture of acetonitrfle- methanol-0. 02mol·L-l ammonium phosphate di- basice（6：49：45） ,with the detection wavelength at 230nm. The flow rate was 1.0 mL·min-l, Results：The method can sep- arate Quetiapine from the impurities. The linearity of Quetiapine N - Oxide was obtained in the range of 0. 044 6-2. 67 6μg·mL-1 ,the equation was y = 838 26x - 113 5.9 （ T = 0. 999 9 ） and the average recoveries of Quetiapine N - Oxide was 101.0% （RSD =0. 04% ）. Conduslon：The method was simple,accurate,and reproducible. It can be used to determinate the related components in Quetiapine Fumarate Extended- release Tablets.

关 键 词：富马酸喹硫平缓释片 喹硫平氮氧化物 有关物质 HPLC 

分 类 号：R927.2[医药卫生—药学]