目的 建立測定富馬酸喹硫平緩釋片含量及4種有關(guān)物質(zhì)的HPLC方法。方法 采用ZorBAX Eclipse XDB-C8柱（4.6 mm×250 mm，5 μm），以甲醇-乙腈-0.02 mol/L磷酸氫二銨溶液（54：7：39）為流動相，體積流量為1.0 mL/min；柱溫為30℃；檢測波長為230 nm。結(jié)果 在該色譜條件下，有關(guān)物質(zhì)與主成分分離度良好，R均大于1.5；富馬酸喹硫平在80~320 μg/mL線性良好，r=0.999 7，檢測限為0.025 μg/mL；平均回收率為99.9%（RSD=1.7%，n=9）。結(jié)論 該方法簡便、靈敏、重復(fù)性好，可用于同時測定富馬酸喹硫平緩釋片的含量及4種有關(guān)物質(zhì)。

Objective To establish a HPLC method for determination of the content and four related substances of quetiapine fumarate extended-release tablets. Method The separation was performed on a ZorBAX Eclipse XDB-C8 column (4.6 mm×250 mm, 5 μm); The mobile phase was methanol-acetonitrile-0.02 mol/L diammonium phosphate solution (54:7:39) at a flow rate of 1.0 mL/min; The column temperature was 30℃; The detection wavelength was 230 nm. Results Related substances were completely separated from the major constituents, with the resolutions were more than 1.5. While a good linearity was found over the range of 80-320 μg/mL, r=0.999 7,with a detection limit of 0.025 μg/mL and it's average recovery was 99.9% (RSD=1.7%, n=9). Conclusion A simple, sensitive and reproducible determination method of the content and four related substances of quetiapine extended-release tablets was established.