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辛伐他汀片中有关物质的HPLC测定
Determination of Related Substances in Simvastatin Tablets by HPLC
【摘要】 建立了HPLC法测定辛伐他汀片中有关物质。采用VP-ODS(250mm×4.6mm,5μm)色谱柱,乙腈-0.025mol/L磷酸二氢钠溶液(pH4.5)(6535)为流动相,检测波长238nm,柱温35℃,流速1mL/min。在0.1-3.0μg/mL范围内线性关系良好(r=0.9999),该方法分离度好,塔板数高,最低检测量可达0.2μg。
【Abstract】 The HPLC method for determination of related substances in simvastatin tablets was established. A VP-ODS(250mm×4.6mm,5μm) column was used with the mobile phase of acetonitrile-0.025mol/L sodium dihydrogen phosphate solution(pH4.5) (65:35),at the detection wavelength of 238nm and the column temperature of 35℃.The flow rate was 1.0ml/min.The calibration curve was linear in the ranger of 0.1-3.0μg/ml (r=0.9999). The determination limit was 0.2μg.
【关键词】 高效液相色谱;
辛伐他汀片;
有关物质;
测定;
【Key words】 HPLC; Simvastatin Tablets; Related substances; Determination;
【Key words】 HPLC; Simvastatin Tablets; Related substances; Determination;
- 【文献出处】 浙江化工 ,Zhejiang Chemical Industry , 编辑部邮箱 ,2005年06期
- 【分类号】TQ463.2
- 【被引频次】6
- 【下载频次】188