Objective To establish an efficient and accurate HPLC method for determination of the content and related substances of quetiapine extended-release tablets. Method Elite Hypersil BDS-C18chromatographic column(4. 6 mm x 150 mm,5 μm) was used, the mobile phase consistsed of buffer solution ( pH 6. 8) -methanol ( 37:63) , the flow rate was 1 ml/min, the wavelength for UV detection was 289 nm. Results There was a good linear relationship in the range of 0. 1008-1. 008 mg/ml, r =0. 9999; the average recovery of the method was 98. 0% -102. 0% , RSD =0. 6% , the reproducibility and precision were good (RSD < 2% ) ; the detection limit of quetiapine was 0. 4 ng and quantitation limit was 1. 2 ng. Conclusion This HPLC method is accurate and efficient for determination of the content and related substances of quetiapine extended-release tablets.%目的 建立能够同时、快速、准确测定喹硫平缓释片含量及有关物质的高效液相色谱( HPLC)方法.方法 色谱柱为Elite Hypersil BDS-C18柱(4.6mm×150mm,5μm),流动相为缓冲液(pH6.8)-甲醇(37∶63),流速1ml/min,检测波长289 nm.结果 药物浓度在0.1008～1.008 mg/ml范围内,峰面积与浓度呈线性关系,r=0.9999；该方法高、中、低浓度供试品的平均回收率均在98.0％～102.0％,RSD为0.6％；重复性及中间精密度的RSD均小于2％；检测限为0.4 ng,定量限为1.2 ng.结论 该方法可以同时快速、准确地测定喹硫平缓释片的含量及有关物质.
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