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[摘要]
目的 建立测定富马酸喹硫平缓释片含量及4种有关物质的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磷酸氢二铵溶液(54:7:39)为流动相,体积流量为1.0 mL/min;柱温为30℃;检测波长为230 nm。结果 在该色谱条件下,有关物质与主成分分离度良好,R均大于1.5;富马酸喹硫平在80~320 μg/mL线性良好,r=0.999 7,检测限为0.025 μg/mL;平均回收率为99.9%(RSD=1.7%,n=9)。结论 该方法简便、灵敏、重复性好,可用于同时测定富马酸喹硫平缓释片的含量及4种有关物质。
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[Abstract]
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.
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