| 引用本文: | 刘秋连,胡翮.HPLC-ELSD和IC-ICD检测磺丁基-β-环糊精中的杂质离子[J].中国现代应用药学,2020,37(9):1075-1079. |
| LIU Qiulian,HU He.Determination of Impurity Ions in Sulfobutyl-β-cyclodextrin by HPLC-ELSD and IC-ICD[J].Chin J Mod Appl Pharm(中国现代应用药学),2020,37(9):1075-1079. |
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| 摘要: |
| 目的 建立了高效液相色谱-蒸发光散射法（HPLC-ELSD）及离子色谱-抑制电导检测法（IC-ICD）测定磺丁基-β-环糊精中氯化钠、4-羟基-1-丁烷磺酸钠、双（4-磺丁基）醚二钠3种杂质含量的方法。方法 HPLC-ELSD采用CD-Screen-IEC柱（4 mm×150 mm，3 μm），梯度洗脱，流速为1.2 mL·min-1；IC-ICD采用Dionex IonPac AS19（4 mm×250 mm）阴离子交换色谱柱分离，30 mmol·L-1氢氧化钠溶液为淋洗液，等度洗脱，流速为1.0 mL·min-1。结果 2种方法各组分分离度良好，HPLC-ELSD法中氯化钠、4-羟基-1-丁烷磺酸钠、双（4-磺丁基）醚二钠检出限（S/N=3）分别为0.230，0.270和0.340 ng，IC-ICD法检出限分别为0.041，0.027和0.014 ng。结论 HPLC-ELSD和IC-ICD在磺丁基-β-环糊精中氯化钠、4-羟基-1-丁烷磺酸钠、双（4-磺丁基）醚二钠3种杂质的含量测定结果上没有明显不同，可根据实际情况选择，只是根据2种方法的检出限及定量限值，IC-ICD法灵敏度更高。 |
| 关键词: 高效液相色谱法 离子色谱 磺丁基-β-环糊精 氯化钠 4-羟基-1-丁烷磺酸钠 双(4-磺丁基)醚二钠 |
| DOI：10.13748/j.cnki.issn1007-7693.2020.09.010 |
| 分类号:R917 |
| 基金项目:湖南省食品药品监督管理局食品药品安全科技项目（湘食药科R201809） |
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| Determination of Impurity Ions in Sulfobutyl-β-cyclodextrin by HPLC-ELSD and IC-ICD |
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LIU Qiulian, HU He
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Xiangtan Institute for Food and Drug Control, Xiangtan 411100, China
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| Abstract: |
| OBJECTIVE To establish high performance liquid chromatography-evaporative light scattering(HPLC-ELSD) and ion chromatography-inhibition conductivity detection(IC-ICD) analytical method for sodium chloride, 4-hydroxy-1-butanesulfonate and bis-(4-sulfbutyl) ether disodium of sulfonbutyl-β-cyclodextrin. METHODS HPLC-ELSD method was used for assay and related subsatances test:CD-Screen-IEC column(4 mm×150 mm, 3 μm); gradient elution; flow rate:1.2 mL·min-1. IC-ICD method was used for assay and related subsatances test:Dionex Ionpac AS19 column(4 mm×250 mm); mobile phase:30 mmol·L-1 sodium hydroxide solution for elution; flow rate:1.0 mL·min-1. RESULTS Two methods had good separation of components. The S/N of sodium chloride, sodium 4-hydroxy-1-butane sulfonate and bis-(4-sulfobutyl) ether disodium in HPLC-ELSD method is 0.230, 0.270 and 0.340 ng, respectively. The limit of detection of IC-ICD is 0.041, 0.027 and 0.014 ng. CONCLUSION There is no obvious difference between HPLC-ELSD and IC-ICD in three impurities content determination of sodium chloride, 4-hydroxy-1-butanesulfonate and bis-(4-sulfobutyl) ether disodium of sulfonbutyl-β-cyclodextrin. It can be selected according to the actual situation. Only according to the detection limit and quantitative limit of the two methods, IC-ICD has higher sensitivity. |
| Key words: HPLC ion chromatography sulfonbutyl-β-cyclodextrin sodium chloride 4-hydroxy-1-butanesulfonate bis-(4-sulfobutyl) ether disodium |
