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目的:建立磺丁基醚-β-环糊精中4-羟基丁磺酸的离子色谱检测方法。方法:采用IonPac AS23阴离子型交换柱(250 mm×4 mm)为分析柱,IonPac AG23(50 mm×4 mm)为保护柱,7 mmol.L-1NaHCO3水溶液为淋洗液,流速为1.0 mL.min-1,以电导检测器检测。结果:在建立的色谱条件下,磺丁基醚-β-环糊精样品中4-羟基丁磺酸与其他杂质离子实现基线分离,4-羟基丁磺酸在2～20 mg.L-1范围内线性良好(r=0.999 8),平均回收率为100.2%(RSD=1.3%,n=9),检测限与定量限分别为2和5 ng。结论:该方法操作简便,结果准确、可靠,适用于磺丁基醚-β-环糊精中4-羟基丁磺酸的限量检查。
Objective: To establish a method for the determination of 4-hydroxybutanesulfonic acid in sulfobutylether-β-cyclodextrin by ion chromatography. Methods: IonPac AS23 anion exchange column (250 mm × 4 mm) was used as the analytical column. IonPac AG23 (50 mm × 4 mm) was used as the guard column, and the aqueous solution of 7 mmol.L-1 NaHCO3 was eluted at a flow rate of 1.0 mL. min-1, with the conductivity detector test. Results: Under the established chromatographic conditions, baseline separation of 4-hydroxybutanesulfonic acid and other impurity ions in the sulfobutylether-β-cyclodextrin sample was achieved with 4-hydroxybutanesulfonic acid at 2 to 20 mg · L -1 The linearity was good (r = 0.999 8) with an average recovery of 100.2% (RSD = 1.3%, n = 9) with limits of detection of 2 and 5 ng, respectively. Conclusion: The method is simple, accurate and reliable. It is suitable for the limit test of 4-hydroxybutanesulfonic acid in sulfobutylether-β-cyclodextrin.