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,3μm),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。
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,3μm);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.
作者
刘秋连
胡翮
LIU Qiulian;HU He(Xiangtan Institute for Food and Drug Control,Xiangtan 411100,China)
出处
《中国现代应用药学》
CAS
CSCD
北大核心
2020年第9期1075-1079,共5页
Chinese Journal of Modern Applied Pharmacy
基金
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)。
