高效液相色谱法测定磺丁基-β-环糊精中的β-环糊精残留含量

目的: 建立磺丁基-β-环糊精中有关物质β-环糊精检测及含量测定的高效液相色谱分析。 方法: 采用Waters XTerra Ms-C₁₈ (4.6 mm×250 mm,5 μm)柱;流动相:甲醇-水(8∶ 92);检测器:示差折光率检测器;流速:0.8 mL·min^-1 ;柱温:25 ℃。 结果: 在所选定的色谱条件下,磺丁基-β-环糊精与β-环糊精能分离完全;β-环糊精在0.1~1.6 mg·mL^-1 内,峰面积与浓度线性关系良好,r=0.9999;最低检测限为2 μg。 结论: 方法简便,准确,专属性强,可用于磺丁基-β-环糊精中的β-环糊精检测及含量测定质量控制。

Objective: To develop a HPLC method for the determination of sufobutylether-β-cyclodenxtin and β-cyclodenxtin for quality control. Methods: The separation was carried out on a Waters XTerra Ms-C₁₈ column (4.6 mm×250 mm,5 μm),using a mixture of methanol-water(8∶ 92)as the mobile phase at a flow rate of 0.8 mL·min^-1.The Refractive Index Detection,the column temperature was 25 ℃. Results: Under the established chromatographic conditions,sufobutylether-β-cyclodenxtin and β-cyclodenxtin were separated completely.The standard curve was linear within the range of 0.0625-1.5 mg·L^-1 with the correlation coefficient of 0.9999,the limit of detection was 0.1 mg. Conclusion: The established method is simple,accurate,specific and can be used for quality control of sufobutylether-β-cyclodenxtin.